Butalbital, Acetaminophen, and Caffeine
Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
Approved
Approval ID
f36970e8-9905-43cb-8cfd-693545f183cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2014
Manufacturers
FDA
RxChange Co.
DUNS: 781126805
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Butalbital, Acetaminophen, and Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33358-059
Application NumberANDA200243
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Acetaminophen, and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2014
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT