NDC Code(s) : 65862-596-01, 65862-596-02
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clindamycin Palmitate Hydrochloride (Pediatric) Clindamycin Palmitate Hydrochloride (Pediatric) SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-596
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PALMITATE HYDROCHLORIDE(UNII: VN9A8JM7M7)
(CLINDAMYCIN - UNII:3U02EL437C) 		CLINDAMYCIN75 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ICODEXTRIN(UNII: 2NX48Z0A9G)
ETHYLPARABEN(UNII: 14255EXE39)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLOXAMER 188(UNII: LQA7B6G8JG)
DIMETHICONE(UNII: 92RU3N3Y1O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCROSE(UNII: C151H8M554)
CHERRY(UNII: BUC5I9595W)
Product Characteristics
Color WHITE Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-596-011 in 1 CARTON 30/04/2013
1100 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:65862-596-021 in 1 CARTON 14/11/2022
2100 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202409 04/30/2013

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917642 ANALYSIS(65862-596), MANUFACTURE(65862-596)

PRINCIPAL DISPLAY PANEL


NDC 65862-596-01
 Rx only 
Clindamycin Palmitate
Hydrochloride
for Oral Solution, USP (Pediatric) 
75 mg*/5 mL
when reconstituted 
AUROBINDO              100 mL (when mixed)



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg/5 mL (100 mL Bottle)

PRINCIPAL DISPLAY PANEL


NDC 65862-596-01

Clindamycin
Palmitate
Hydrochloride for
Oral Solution, USP
( Pediatric)
75 mg*/5 mL

when reconstituted
Rx only              100 mL (when mixed)


AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg/5 mL Container Carton Label