NDC 0904-5309

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Ibuprofen.

Product ID0904-5309_79a46f8f-e792-448e-8dd6-2b9eee6303c0
NDC0904-5309
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date1999-02-07
Marketing CategoryANDA / ANDA
Application NumberANDA074937
Labeler NameMajor Pharmaceuticals
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0904-5309-09

1 BOTTLE in 1 CARTON (0904-5309-09) > 240 mL in 1 BOTTLE
Marketing Start Date2003-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-5309-20 [00904530920]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1999-02-07

NDC 0904-5309-09 [00904530909]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2003-12-09

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:847758ed-66fc-4db9-8fdb-78f3c3291a03
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197803
  • 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

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