DEMEROL: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 75 mg/mL Cartridge Label

1 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock

Rx only
NDC 0409-1179-03

Demerol™
meperidine HCl injection, USP
75 mg/mL
CII

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

PAA193037

LOT #####AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 75 mg/mL Cartridge Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/mL Cartridge Carton

NDC 0409-1179-30
Contains 10 of NDC 0409-1179-03
Rx only

1 mL Single-dose

10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

Demerol™
meperidine
hydrochloride
injection, USP
75 mg/mL
CII

For Intramuscular, Subcutaneous, or
Intravenous Use

Carpuject Cartridges are to be used
ONLY with Carpuject Holders.

Dist. by Hospira, Inc.
Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 75 mg/mL Cartridge Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/mL Cartridge Label

1 mL Single-dose Carpuject™
Sterile Cartridge Unit with Luer Lock

Rx only
NDC 0409-1180-59

Demerol™
meperidine HCl injection, USP
100 mg/mL
CII

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

PAA193038

LOT #####AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 100 mg/mL Cartridge Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/mL Cartridge Carton

NDC 0409-1180-69
Contains 10 of NDC 0409-1180-59
Rx only

1 mL Single-dose

10 Carpuject™
Sterile Cartridge Units
with Luer Lock

Needle not included

SLIM-PAK™
Tamper Detection Package

Demerol™
meperidine
hydrochloride
injection, USP
100 mg/mL
CII

For Intramuscular, Subcutaneous, or
Intravenous Use

Carpuject Cartridges are to be used
ONLY with Carpuject Holders.

Dist. by Hospira, Inc.,
Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 100 mg/mL Cartridge Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mL Vial Label

30 mL
Multiple-dose vial

NDC 0409-1181-30
Rx only

Sterile Aqueous Injection

Demerol™
meperidine hydrochloride injection, USP
1500 mg/30 mL (50 mg/mL)
CII

For Intramuscular, Subcutaneous, or Intravenous Use

Distributed by
Hospira, Inc., Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 30 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mL Vial Carton

NDC 0409-1181-30
Rx only
NSN 6505-00-126-9360

30 mL Multiple-dose vial

Demerol™
meperidine
hydrochloride
injection, USP
1500 mg/30 mL
(50 mg/mL)
CII

For Intramuscular, Subcutaneous,or Intravenous Use

Sterile Aqueous Injection

Hospira

PRINCIPAL DISPLAY PANEL -- 30 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg/mL Syringe Chamber Label

Demerol™
meperidine HCl injection, USP
CII
25 mg/mLPAA148095

PRINCIPAL DISPLAY PANEL -- 25 mg/mL Syringe Chamber Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg/mL Syringe Luer Label

TWIST & PULL

Tamper Seal

NDC 0409-1362-11
CII

Demerol™
meperidine HCl injection, USP

25 mg/mL

Intramuscular,
Subcutaneous, or
Intravenous Use
Rx only

1 mL Single-dose syringe

PAA148096

LOT #####AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 25 mg/mL Syringe Luer Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg/mL Syringe Cello Pack

NDC 0409-1362-01
Demerol™
CII
meperidine hydrochloride
injection, USP

25 mg / mL

For Intramuscular, Subcutaneous, or Intravenous Use

10 NexJect™ 1 mL Single-dose syringes with luer lock
Rx only
Needle not included

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between
15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
Sterile Aqueous Injection

Each mL contains 25 mg meperidine hydrochloride (equivalent to 21.79 mg
meperidine), 3.8 mg sodium chloride for isotonicity, NaOH and HCl for pH
adjustment, in water for injection.

For usual pediatric dosage and route of administration, see package insert.
Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.

PAA189910
Distributed by Hospira, Inc.
Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 25 mg/mL Syringe Cello Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg/mL Syringe Chamber Label

Demerol™
meperidine HCl injection, USP
CII
50 mg/mLPAA148098

PRINCIPAL DISPLAY PANEL -- 50 mg/mL Syringe Chamber Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg/mL Syringe Luer Label

TWIST & PULL

Tamper Seal

NDC 0409-1418-11
CII

Demerol™
meperidine HCl injection, USP

50 mg/mL

Intramuscular,
Subcutaneous, or
Intravenous Use
Rx only
1 mL Single-dose syringe

PAA148099

LOT #####AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 50 mg/mL Syringe Luer Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg/mL Syringe Cello Pack

NDC 0409-1418-01
Demerol™
CII
meperidine hydrochloride
injection, USP

50 mg / mL

For Intramuscular, Subcutaneous, or Intravenous Use

10 NexJect™ 1 mL Single-dose syringes with luer lock
Rx only
Needle not included

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between
15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]
Sterile Aqueous Injection

Each mL contains 50 mg meperidine hydrochloride (equivalent to 43.58 mg
meperidine), NaOH and HCl for pH adjustment, in water for injection.
For usual dosage and route of administration, see package insert.
Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.

PAA189961
Distributed by Hospira, Inc.
Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 50 mg/mL Syringe Cello Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/mL Syringe Chamber Label

Demerol™
meperidine HCl injection, USP
CII
75 mg/mLPAA148383

PRINCIPAL DISPLAY PANEL -- 75 mg/mL Syringe Chamber Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/mL Syringe Luer Label

TWIST & PULL

Tamper Seal

NDC 0409-2033-11
CII

Demerol™
meperidine HCl injection, USP

75 mg/mL

Intramuscular,
Subcutaneous, or
Intravenous Use
Rx only
1 mL Single-dose syringe

PAA148381

LOT #####AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 75 mg/mL Syringe Luer Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg/mL Syringe Cello Pack

NDC 0409-2033-01
Demerol™
CII
meperidine hydrochloride
injection, USP

75 mg / mL

For Intramuscular, Subcutaneous, or Intravenous Use

10 NexJect™ 1 mL Single-dose syringes with luer lock
Rx only
Needle not included

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Sterile Aqueous Injection

pH adjusted with NaOH or HCl.
For usual dosage and route of administration, see package insert.
Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.

PAA148382
Hospira, Inc.
Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 75 mg/mL Syringe Cello Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/mL Syringe Chamber Label

Demerol™
meperidine HCl injection, USP
CII
100 mg/mLPAA148385

PRINCIPAL DISPLAY PANEL -- 100 mg/mL Syringe Chamber Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/mL Syringe Luer Label

TWIST & PULL

Tamper Seal

NDC 0409-1377-11
CII

Demerol™
meperidine HCl injection, USP

100 mg/mL

Intramuscular,
Subcutaneous, or
Intravenous Use
Rx only
1 mL Single-dose syringe

PAA148386

LOT #####AAEXP DMMMYYYY

PRINCIPAL DISPLAY PANEL -- 100 mg/mL Syringe Luer Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/mL Syringe Cello Pack

NDC 0409-1377-01
Demerol™
CII
meperidine hydrochloride
injection, USP

100 mg / mL

For Intramuscular, Subcutaneous, or Intravenous Use

10 NexJect™ 1 mL Single-dose syringes with luer lock
Rx only
Needle not included

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Sterile Aqueous Injection

pH adjusted with NaOH or HCl.
For usual dosage and route of administration, see package insert.
Demerol™ is a registered trademark of Sanofi Pharmaceuticals, Inc.

PAA148384
Hospira, Inc.
Lake Forest, IL 60045 USAHospira

PRINCIPAL DISPLAY PANEL -- 100 mg/mL Syringe Cello Pack
(click image for full-size original)
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1181
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METACRESOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1181-30 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0409-1181-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 02/24/2006
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1176
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1176-30 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1176-03)
1 NDC:0409-1176-03 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1176-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 08/25/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1178
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1178-30 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1178-03)
1 NDC:0409-1178-03 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1178-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 09/13/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1179
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1179-30 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1179-03)
1 NDC:0409-1179-03 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1179-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 10/12/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1180
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1180-69 10 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0409-1180-59)
1 NDC:0409-1180-59 1 mL in 1 CARTRIDGE This package is contained within the CARTON (0409-1180-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 09/15/2005
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1362
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1362-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-1362-11)
1 NDC:0409-1362-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-1362-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1418
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1418-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-1418-11)
1 NDC:0409-1418-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-1418-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-2033
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-2033-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-2033-11)
1 NDC:0409-2033-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-2033-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021 04/16/2021
DEMEROL meperidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1377
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEPERIDINE HYDROCHLORIDE (MEPERIDINE) MEPERIDINE HYDROCHLORIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1377-01 10 SYRINGE in 1 CELLO PACK contains a SYRINGE (0409-1377-11)
1 NDC:0409-1377-11 1 mL in 1 SYRINGE This package is contained within the CELLO PACK (0409-1377-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021171 04/16/2021 04/16/2021
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (0409-1176), ANALYSIS (0409-1178), ANALYSIS (0409-1179), ANALYSIS (0409-1180), ANALYSIS (0409-1181), ANALYSIS (0409-1362), ANALYSIS (0409-1377), ANALYSIS (0409-1418), ANALYSIS (0409-2033), MANUFACTURE (0409-1176), MANUFACTURE (0409-1178), MANUFACTURE (0409-1179), MANUFACTURE (0409-1180), MANUFACTURE (0409-1181), MANUFACTURE (0409-1362), MANUFACTURE (0409-1377), MANUFACTURE (0409-1418), MANUFACTURE (0409-2033), PACK (0409-1176), PACK (0409-1178), PACK (0409-1179), PACK (0409-1180), PACK (0409-1181), PACK (0409-1362), PACK (0409-1377), PACK (0409-1418), PACK (0409-2033), LABEL (0409-1176), LABEL (0409-1178), LABEL (0409-1179), LABEL (0409-1180), LABEL (0409-1181), LABEL (0409-1362), LABEL (0409-1377), LABEL (0409-1418), LABEL (0409-2033)

Revised: 11/2022 Hospira, Inc.

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