NDC 36800-993

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates, Llc. The primary component is Ibuprofen.

Product ID36800-993_2ff6f80b-5fa2-4331-8dc3-4306ccb58138
NDC36800-993
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1999-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA075139
Labeler NameTopco Associates, LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 36800-993-06

200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-993-06)
Marketing Start Date1999-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-993-06 [36800099306]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075139
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-03-01

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:bcf7d4c1-1f99-48df-8f74-9abeefa8d41d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0036800495807
  • 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.