NDC Code(s) : 57664-185-31, 57664-185-34
Packager : Sun Pharmaceutical Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-185
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I)
(PROMETHAZINE - UNII:FF28EJQ494) 		PROMETHAZINE HYDROCHLORIDE6.25 mg in 5 mL
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J) 		CODEINE PHOSPHATE10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color GREEN Score
Shape Size
Flavor PINEAPPLE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-185-31118 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:57664-185-34473 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090180 03/17/2010

PRINCIPAL DISPLAY PANEL

NDC 57664-185-34

    Promethazine
Hydrochloride and
Codeine Phosphate
          Syrup

6.25 mg and 10 mg/5 mL

Alcohol 7% v/v

16 fl. Oz. (473 mL)


Rx Only



PromethazineCodeined_label