Butalbital, Aspirin, and Caffeine
Butalbital, Aspirin, and Caffeine Capsules, USP
Approved
Approval ID
a1c7b964-af71-4427-8f13-73b5e69ca525
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2021
Manufacturers
FDA
LGM Pharma Solutions, LLC
DUNS: 117549198
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 Code79739-7192
Application NumberANDA205230
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Aspirin, and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2021
FDA Product Classification
INGREDIENTS (7)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ASPIRINActive
Quantity: 500 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT