Butalbital, acetaminophen, and caffeine tablet

Ingredients and appearance - Product information

Butalbital, acetaminophen, and caffeine tablet- Butalbital, acetaminophen, and caffeine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68071-3249
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Butalbital ( UNII: KHS0AZ4JVK)( Butalbital - UNII: KHS0AZ4JVK ) 50 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Caffeine ( UNII: 3G6A5W338E)( Caffeine - UNII: 3G6A5W338E ) 40 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Crospovidone ( UNII: 2S7830E561)
Croscarmellose sodium ( UNII: M28OL1HH48)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)

Product Characteristics

Color blue (Light-blue, speckled) Imprint Code LCI;1695
Score 1 Shape ROUND
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68071-3249-2 20 in 1 BOTTLE 2017/05/05
2 NDC: 68071-3249-3 30 in 1 BOTTLE 2017/05/05
3 NDC: 68071-3249-6 60 in 1 BOTTLE 2017/05/05
4 NDC: 68071-3249-0 10 in 1 BOTTLE 2017/08/16

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200243 USA 2017/08/16

Labeler - NuCare Pharmaceuticals, Inc.( 010632300)

Establishment

Name ID/FEI Business Operations
NuCare Pharmaceuticals, Inc. 010632300 repack( 68071-3249)