BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Butalbital, Acetaminophen and Caffeine Capsules, USP
Approved
Approval ID
ee7630f8-f4b8-4eb0-b34d-d908567030c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2022
Manufacturers
FDA
SUNRISE PHARMACEUTICAL, INC
DUNS: 168522378
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 Code11534-187
Application NumberANDA207118
Product Classification
M
Marketing Category
C73584
G
Generic Name
butalbital, acetaminophen and caffeine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2020
FDA Product Classification
INGREDIENTS (10)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT