Butalbital, Acetaminophen and Caffeine
Butalbital, Acetaminophen, and Caffeine Capsules 50 mg / 300 mg / 40 mg
Approved
Approval ID
56d6c70e-b2c0-0276-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2022
Manufacturers
FDA
Xspire Pharma, LLC
DUNS: 078312042
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 Code42195-955
Application NumberANDA206615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Acetaminophen and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2022
FDA Product Classification
INGREDIENTS (19)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT