Butalbital, Aspirin and Caffeine
Butalbital, Aspirin and Caffeine Tablets, USP CIII
Approved
Approval ID
ce47777f-8cf7-4f53-b48f-165b83516896
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2018
Manufacturers
FDA
Vensun Pharmaceuticals, Inc.
DUNS: 078310501
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Butalbital, Aspirin and Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-098
Application NumberANDA204195
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Aspirin and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2016
FDA Product Classification
INGREDIENTS (9)
ButalbitalActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
CaffeineActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
AspirinActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Hydrogenated Cottonseed OilInactive
Code: Z82Y2C65EA
Classification: IACT