NDC Code(s) : 54868-3695-0
Packager : Physicians Total Care, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clindamycin Phosphate clindamycin phosphate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3695(NDC:0409-4050-01)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE(UNII: EH6D7113I8)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN PHOSPHATE150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)0.5 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)9.45 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54868-3695-01 in 1 CASE
125 in 1 TRAY
12 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062801 02/27/1997

LABELER - Physicians Total Care, Inc.(194123980)

Establishment
Name Address ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel

PRINCIPAL DISPLAY PANEL

Clindamycin Injection, USP (300 mg/2 mL)

image of package label