NDC Code(s) : 0703-2191-01, 0703-2191-04, 0703-2201-01, 0703-2201-04
Packager : Teva Parenteral Medicines, Inc.

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:0703-2191
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)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
PHENOL(UNII: 339NCG44TV)
WATER(UNII: 059QF0KO0R)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM ACETATE(UNII: 4550K0SC9B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0703-2191-0425 in 1 TRAY
1NDC:0703-2191-011 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040454 10/01/2002
Promethazine HydrochloridePromethazine Hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0703-2201
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 HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
PHENOL(UNII: 339NCG44TV)
WATER(UNII: 059QF0KO0R)
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM ACETATE(UNII: 4550K0SC9B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0703-2201-0425 in 1 TRAY
1NDC:0703-2201-011 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040454 10/01/2002

PRINCIPAL DISPLAY PANEL

Promethazine Hydrochloride Injection, USP 25 mg/mL, 1mL Single Dose Vial x 25 Tray Label

PRINCIPAL DISPLAY PANEL

Promethazine Hydrochloride Injection, USP 50 mg/mL, 1mL Single Dose Vial x 25 Tray Label