Acetaminophen and codeine phosphate tablet

Ingredients and appearance - Product information

Acetaminophen and codeine phosphate tablet- Acetaminophen and codeine phosphate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68788-9506
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 300 mgin 1
Codeine phosphate ( UNII: GSL05Y1MN6)( Codeine anhydrous - UNII: UX6OWY2V7J ) 30 mgin 1

Inactive Ingredients

Ingredient Name Code
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color WHITE (to off-white) Size 11 mm
Shape ROUND Score 1
Imprint Code 3;M

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040419 USA

Labeler - Preferred Pharmaceuticals, Inc.( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK( 68788-9506)