Butalbital, Aspirin, and Caffeine
Butalbital, Aspirin, and Caffeine Capsules, USP C-III
Approved
Approval ID
6fb46842-069c-42b8-a9e0-ffe454517d1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2021
Manufacturers
FDA
Nostrum Laboratories, Inc.
DUNS: 791142354
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 Code29033-215
Application NumberANDA078149
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Aspirin, and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2022
FDA Product Classification
INGREDIENTS (17)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT