Butalbital, Acetaminophen, Caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 50 mg/325 mg/40 mg
Approved
Approval ID
d860af16-fab4-4263-9e66-a648d5e81dab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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
NDC Product Code71205-981
Application NumberANDA209587
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 1, 2023
Generic NameButalbital, Acetaminophen, and Caffeine
INGREDIENTS (9)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
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
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT