Butalbital, Aspirin, Caffeine and Codeine Phosphate
Approved
Approval ID
787cda7d-7aa4-4909-8e5c-f2fcf68828e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Butalbital, Aspirin, Caffeine and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1037
Application NumberANDA074359
Product Classification
M
Marketing Category
C73584
G
Generic Name
Butalbital, Aspirin, Caffeine and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification
INGREDIENTS (14)
BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIM
CAFFEINEActive
Quantity: 40 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIM
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIM
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT