NDC Code(s) : 61786-664-20
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clindamycin Palmitate HydrochlorideClindamycin Palmitate Hydrochloride GRANULE, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-664(NDC:0574-0129)
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
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLPARABEN(UNII: 14255EXE39)
ICODEXTRIN(UNII: 2NX48Z0A9G)
POLOXAMER 188(UNII: LQA7B6G8JG)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-664-20100 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product13/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090902 04/13/2016 04/14/2016

PRINCIPAL DISPLAY PANEL

DRUG: Clindamycin Palmitate Hydrochloride


GENERIC: Clindamycin Palmitate Hydrochloride


DOSAGE: GRANULE, FOR SOLUTION


ADMINSTRATION: ORAL


NDC: 61786-664-20


ACTIVE INGREDIENT(S):

  • CLINDAMYCIN PALMITATE HYDROCHLORIDE 75mg in 5mL


INACTIVE INGREDIENT(S):

  • DIMETHICONE
  • ETHYLPARABEN
  • ICODEXTRIN
  • POLOXAMER 188
  • SILICON DIOXIDE
  • SUCROSE


FLAVOR: CHERRY


PACKAGING: 100 mL in 1 BOTTLE, GLASS


OUTER PACKAGING: 1 in 1 CARTON




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