Dihydrocodeine Bitartrate, Acetaminophen and Caffeine
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets
Approved
Approval ID
f3ddb645-028a-4c54-96b9-dbfecacf19bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2009
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.
Dihydrocodeine Bitartrate, Acetaminophen and Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5900
Application NumberANDA040701
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dihydrocodeine Bitartrate, Acetaminophen and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2011
FDA Product Classification
INGREDIENTS (9)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CAFFEINEActive
Quantity: 60 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACETAMINOPHENActive
Quantity: 712.8 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DIHYDROCODEINE BITARTRATEActive
Quantity: 32 mg in 1 1
Code: 8LXS95BSA9
Classification: ACTIB