NDC Code(s) : 55289-916-20, 55289-916-30, 55289-916-90
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acetaminophen And Codeineacetaminophen and codeine phosphate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-916(NDC:0603-2339)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J) 		CODEINE PHOSPHATE60 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN300 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 12 mm
Flavor Imprint Code 2065;V;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55289-916-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2009
2NDC:55289-916-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2009
3NDC:55289-916-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089828 09/30/1988

PRINCIPAL DISPLAY PANEL

55289916 label