Hydrocodone Bitartrate and Ibuprofen
HYDROCODONE BITARTRATE and IBUPROFEN TABLETS 7.5 mg/200 mg
Approved
Approval ID
a0344b3f-d289-43c6-bcb7-3cebf97c7cdc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-656
Application NumberANDA077723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2012
FDA Product Classification
INGREDIENTS (12)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT