Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Blenheim Pharmacal, Inc.
171434587
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
Blenheim Pharmacal, Inc.
171434587
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IBU
Product Details
NDC Product Code
10544-625Application Number
ANDA075682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 19, 2015CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 400 mg in 1 1
IBU
Product Details
NDC Product Code
10544-071Application Number
ANDA075682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 19, 2015SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT