Clindamycin in 5 Percent Dextrose: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED

Clindamycin in 5% Dextrose Injection in Cryovac plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. Each 50 mL contains clindamycin phosphate equivalent to 600 mg or 900 mg clindamycin. The single dose Cryovac plastic containers are available as follows:

600 mg/50 mL, Carton of 24 minibags

NDC 72572-074-24

900 mg/50 mL, Carton of 24 minibags

NDC 72572-076-24

Exposure of pharmaceutical products to heat should be minimized. It is recommended that Cryovac plastic containers be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30° C.

REFERENCES

1.
Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.

Distributed by: Civica, Inc., Lehi, Utah 84043

Manufactured by: InfoRLife SA, Campascio, Switzerland

Rev. March 2021

L128USCLIN00

Package/Label Display Panel

NDC 72572-074 -24

Clindamycin

in 5% Dextrose Injection

600 mg/50 mL

For Intravenous Use

24 x 50 mL Single Dose Containers

CIVICA

Rx Only

Sterile, Nonpyrogenic

600mg_carton
(click image for full-size original)

Package/Label Display Panel

NDC 72572-076-24

Clindamycin

in 5% Dextrose Injection

900 mg/50 mL

For Intravenous Use

24 x 50 mL Single Dose Containers

CIVICA

Rx Only

Sterile, Nonpyrogenic

900mg_carton
(click image for full-size original)
CLINDAMYCIN IN 5 PERCENT DEXTROSE
clindamycin in 5 percent dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-074
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN (CLINDAMYCIN) CLINDAMYCIN 12 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 50 mg in 1 mL
EDETATE DISODIUM 0.04 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72572-074-24 24 BAG in 1 CARTON contains a BAG (72572-074-01)
1 NDC:72572-074-01 50 mL in 1 BAG This package is contained within the CARTON (72572-074-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201692 01/13/2022
CLINDAMYCIN IN 5 PERCENT DEXTROSE
clindamycin in 5 percent dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-076
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN (CLINDAMYCIN) CLINDAMYCIN 18 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 50 mg in 1 mL
EDETATE DISODIUM 0.04 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72572-076-24 24 BAG in 1 CARTON contains a BAG (72572-076-01)
1 NDC:72572-076-01 50 mL in 1 BAG This package is contained within the CARTON (72572-076-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201692 01/13/2022
Labeler — Civica, Inc. (081373942)

Revised: 01/2022 Civica, Inc.

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