NDC 55289-916-20
API & Excipient Details

Codeine Phosphate marketed by PD-Rx Pharmaceuticals, Inc. under NDC Code 55289-916-20

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CODEINE PHOSPHATE(UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	60 mg
ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	300 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55289-916-20	20 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	09/01/2009
2	NDC:55289-916-30	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	09/01/2009
3	NDC:55289-916-90	90 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	09/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA089828	09/30/1988

PRINCIPAL DISPLAY PANEL