NDC 70934-375

IBUPROFEN

Ibuprofen

IBUPROFEN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. The primary component is Ibuprofen.

Product ID70934-375_8afa98be-80f7-3129-e053-2a95a90aba6d
NDC70934-375
Product TypeHuman Prescription Drug
Proprietary NameIBUPROFEN
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-30
Marketing CategoryANDA / ANDA
Application NumberANDA090796
Labeler NameDenton Pharma, Inc. DBA Northwind Pharmaceuticals
Substance NameIBUPROFEN
Active Ingredient Strength600 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70934-375-20

20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-375-20)
Marketing Start Date2019-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70934-375-30 [70934037530]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-27

NDC 70934-375-60 [70934037560]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-14

NDC 70934-375-40 [70934037540]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

NDC 70934-375-20 [70934037520]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-29

NDC 70934-375-90 [70934037590]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-30

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN600 mg/1

OpenFDA Data

SPL SET ID:78475aff-f72b-a6a1-e053-2a91aa0a3ae6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197807
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    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.