NDC 0904-7912

ibuprofen

Ibuprofen

ibuprofen is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Ibuprofen.

Product ID0904-7912_43700d2b-4063-4ae9-86d8-6e22b0c55118
NDC0904-7912
Product TypeHuman Otc Drug
Proprietary Nameibuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1994-08-16
Marketing CategoryANDA / ANDA
Application NumberANDA072096
Labeler NameMajor Pharmaceuticals
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-7912-51

1 BOTTLE in 1 CARTON (0904-7912-51) > 50 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date1994-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-7912-59 [00904791259]

ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1994-08-30

NDC 0904-7912-24 [00904791224]

ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1998-06-17

NDC 0904-7912-51 [00904791251]

ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA072096
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date1994-08-16

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:03993008-7bd2-465f-b5a9-1cbc3c1fff02
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • NDC Crossover Matching brand name "ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    67877-120ibuprofenibuprofen
    67877-119ibuprofenibuprofen
    67877-295ibuprofenibuprofen
    67877-121ibuprofenibuprofen
    67877-294ibuprofenibuprofen
    67877-296ibuprofenibuprofen
    67877-321IbuprofenIbuprofen
    67877-319IbuprofenIbuprofen
    67877-320IbuprofenIbuprofen
    68016-116IbuprofenIbuprofen
    68016-633IbuprofenIbuprofen
    68016-626IbuprofenIbuprofen
    68016-634IbuprofenIbuprofen
    68016-645IbuprofenIbuprofen
    68016-295IbuprofenIbuprofen
    68016-635IbuprofenIbuprofen
    68071-3074IbuprofenIbuprofen
    68071-3362IBUPROFENIBUPROFEN
    68071-4129IbuprofenIbuprofen
    68071-4009IBUPROFENIBUPROFEN
    68071-3388IbuprofenIbuprofen
    68071-4253IbuprofenIbuprofen
    68071-4306IbuprofenIbuprofen
    68071-4357IbuprofenIbuprofen
    68071-4563IbuprofenIbuprofen
    68071-4280IbuprofenIbuprofen
    68071-4243IBUPROFENIBUPROFEN
    68071-4820IbuprofenIbuprofen
    68071-4305IbuprofenIbuprofen
    68071-4459IBUPROFENIBUPROFEN
    68084-703IbuprofenIbuprofen
    68084-658IbuprofenIbuprofen
    68084-772IbuprofenIbuprofen
    68196-980IbuprofenIbuprofen
    68196-981IbuprofenIbuprofen
    68210-0200IBUPROFENIBUPROFEN
    68196-199IbuprofenIbuprofen
    68210-0009IBUPROFENIBUPROFEN
    68196-745IbuprofenIbuprofen
    68387-208IbuprofenIbuprofen
    0472-2002IbuprofenIbuprofen
    68387-210IbuprofenIbuprofen
    68391-121IbuprofenIbuprofen
    68391-199IbuprofenIbuprofen
    0472-1270IbuprofenIbuprofen
    68645-531IbuprofenIbuprofen
    68645-563IbuprofenIbuprofen
    68645-562IbuprofenIbuprofen
    68645-561IbuprofenIbuprofen
    0113-1461basic care childrens ibuprofenIbuprofen
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.