Butalbital and acetaminophen tablet

Ingredients and appearance - Product information

Butalbital and acetaminophen tablet- Butalbital and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43199-053
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Butalbital ( UNII: KHS0AZ4JVK)( Butalbital - UNII: KHS0AZ4JVK ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Starch, corn ( UNII: O8232NY3SJ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Stearic acid ( UNII: 4ELV7Z65AP)
Microcrystalline cellulose ( UNII: OP1R32D61U)

Product Characteristics

Color white Size 14 mm
Score 1 Shape CAPSULE
Imprint Code t255


# Item Code Package Description Marketing Start Date
1 NDC: 43199-053-01 100 in 1 BOTTLE 2015/12/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205120 USA 2015/12/01

Labeler - County Line Pharmaceuticals, LLC( 015585278)