NDC 17856-5309

Ibuprofen

Ibuprofen

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

Product ID17856-5309_2587f64e-02fd-4abf-99c2-62ceb9098226
NDC17856-5309
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date1999-02-07
Marketing CategoryANDA / ANDA
Application NumberANDA074937
Labeler NameAtlantic Biologicals Corps
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-5309-1

5 mL in 1 SYRINGE (17856-5309-1)
Marketing Start Date2021-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-5309-9 [17856530909]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-20

NDC 17856-5309-3 [17856530903]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-20
Marketing End Date2019-09-20

NDC 17856-5309-5 [17856530905]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-09-20

NDC 17856-5309-2 [17856530902]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-20
Marketing End Date2019-09-20

NDC 17856-5309-7 [17856530907]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-20

NDC 17856-5309-1 [17856530901]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-20

NDC 17856-5309-4 [17856530904]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-20

NDC 17856-5309-6 [17856530906]

Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-20

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:230914e6-fe0c-45be-8b2e-e066c71d004c
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.