Clindamycin Palmitate Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Clindamycin palmitate HCl pediatric flavored granules for oral solution is available in bottles of 100 mL (NDC 59762-0016-1).

When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL.

Rx only

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.

LAB-0429-14.0
Revised: 2/2022

PRINCIPAL DISPLAY PANEL — 75 mg Bottle Label

NDC 59762-0016-1
100 mL
(when mixed)

GREENSTONE^® BRAND

clindamycin
palmitate
hydrochloride
for oral solution, USP
For pediatric use

When reconstituted each 5 mL contains
75 mg*

Rx only

PRINCIPAL DISPLAY PANEL — 75 mg Bottle Carton

NDC 59762-0016-1
100 mL
(when mixed)

GREENSTONE^® BRAND

clindamycin
palmitate
hydrochloride
for oral solution, USP
For pediatric use

When reconstituted each 5 mL contains
75 mg*

Rx only

CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-0016 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PALMITATE HYDROCHLORIDE (CLINDAMYCIN) CLINDAMYCIN 75 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ETHYLPARABEN POLOXAMER 188 SUCROSE

Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59762-0016-1 1 BOTTLE in 1 CARTON contains a BOTTLE 1 100 mL in 1 BOTTLE This package is contained within the CARTON (59762-0016-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062644 04/07/1986

Labeler — Greenstone LLC (825560733)

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions, LLC		829672745	ANALYSIS (59762-0016), MANUFACTURE (59762-0016)

Establishment
Name	Address	ID/FEI	Operations
Pharmacia & Upjohn Company LLC		618054084	ANALYSIS (59762-0016), API MANUFACTURE (59762-0016), PACK (59762-0016), LABEL (59762-0016)

Revised: 01/2023 Greenstone LLC