NDC Code(s) : 55154-5127-5
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5127(NDC:0641-0948)
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I)
(PROMETHAZINE - UNII:FF28EJQ494) 		PROMETHAZINE HYDROCHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)0.1 mg in 1 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)0.04 mg in 1 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.25 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5 mg in 1 mL
WATER(UNII: 059QF0KO0R)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM ACETATE(UNII: 4550K0SC9B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5127-55 in 1 BAG
11 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083312 01/26/2010

PRINCIPAL DISPLAY PANEL

Promethazine HCI Injection, USP
25 mg/mL

5 x 1 mL Ampuls

Bag label