Reprexain
REPREXAIN (hydrocodone bitartrate, ibuprofen) tablet, film coated
Approved
Approval ID
fe580e12-03fa-4678-9887-458297007441
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2009
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate, Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-878
Application NumberANDA076642
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate, Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (2)
Hydrocodone BitartrateActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
IbuprofenActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
Hydrocodone Bitartrate, Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-276
Application NumberANDA076642
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate, Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (2)
Hydrocodone BitartrateActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
IbuprofenActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB