Ascomp with Codeine
These highlights do not include all the information needed to use Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP safely and effectively. See full prescribing information for Butalbital, Aspirin, Caffe i ne, and Codeine Phosphate Capsules, USP . B utalbital, A spirin, C affeine, and C odeine P hosphate C apsules, USP for oral use, CIII Initial U.S. Approval: 1990
Approved
Approval ID
1cab3106-1064-4b42-892b-39f405d9e02f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 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, Cafeine, and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code79739-6094
Application NumberANDA075231
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Aspirin, Cafeine, and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2022
FDA Product Classification
INGREDIENTS (15)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT