NDC Code(s) : 52125-636-52
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diphenhydramine Hydrochloridediphenhydramine hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-636(NDC:0641-0376)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE(UNII: PH41D05744)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-636-521 mL in 1 BOTTLE, UNIT-DOSE Type 0: Not a Combination Product30/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080817 04/30/2016 11/16/2016

PRINCIPAL DISPLAY PANEL

DRUG: Diphenhydramine Hydrochloride


GENERIC: diphenhydramine hydrochloride


DOSAGE: INJECTION


ADMINSTRATION: INTRAMUSCULAR


NDC: 52125-636-52


ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1mL


INACTIVE INGREDIENT(S):

  • BENZETHONIUM CHLORIDE
  • SODIUM HYDROXIDE
  • HYDROCHLORIC ACID
  • WATER


PACKAGING: 1 mL in 1 BOTTLE, UNIT-DOSE



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