Amlodipine Besylate: Package Insert and Label Information (Page 4 of 4)

Package/Label Display Panel – Blister – 2.5 mg

2.5 mg Amlodipine Besylate Tablet Blister
(click image for full-size original)

AMLODIPINE BESYLATE TABLET, USP

2.5 mg

Package/Label Display Panel – Carton – 5 mg

5 mg Amlodipine Besylate Tablets Carton
(click image for full-size original)

NDC 60687- 488 -01

AMLODIPINE BESYLATE
TABLETS, USP

5 mg*

100 Tablets (10 x 10)               Rx Only

*Each Tablet Contains:
Amlodipine besylate USP equivalent to 5 mg of amlodipine.

Usual Dosage: See package insert for full prescribing
information.

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

Keep this and all drugs out of reach of children. In case of
accidental overdose, seek professional assistance or contact
a poison control center immediately.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 67877-198, Ascend Laboratories, LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

748801 0448801/0619

Package/Label Display Panel – Blister – 5 mg

5 mg Amlodipine Besylate Tablet Blister
(click image for full-size original)

AMLODIPINE BESYLATE TABLET, USP

5 mg

Package/Label Display Panel – Carton – 10 mg

10 mg Amlodipine Besylate Tablets Carton
(click image for full-size original)

NDC 60687- 496 -01

AMLODIPINE BESYLATE
TABLETS, USP

10 mg*

100 Tablets (10 x 10)               Rx Only

*Each Tablet Contains:
Amlodipine besylate USP equivalent to 10 mg of amlodipine.

Usual Dosage: See package insert for full prescribing
information.

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

Keep this and all drugs out of reach of children. In case of
accidental overdose, seek professional assistance or contact
a poison control center immediately.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 67877-199, Ascend Laboratories, LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

749601 0449601/06

Package/Label Display Panel – Blister – 10 mg

10 mg Amlodipine Besylate Tablet Blister
(click image for full-size original)

AMLODIPINE BESYLATE TABLET, USP

10 mg

AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-477(NDC:67877-197)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (OFF-WHITE) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 211
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-477-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-477-11)
1 NDC:60687-477-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-477-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078925 07/15/2019 09/03/2019
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-488(NDC:67877-198)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (OFF-WHITE) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 210
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-488-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-488-11)
1 NDC:60687-488-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-488-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078925 08/05/2019
AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-496(NDC:67877-199)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (OFF-WHITE) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 209
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-496-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-496-11)
1 NDC:60687-496-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-496-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078925 08/02/2019
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-477), repack (60687-488), repack (60687-496)

Revised: 04/2020 American Health Packaging

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