NDC 43063-872

IBUPROFEN

Ibuprofen

IBUPROFEN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Ibuprofen.

Product ID43063-872_8476e7fa-a0a1-f06b-e053-2991aa0a7331
NDC43063-872
Product TypeHuman Prescription Drug
Proprietary NameIBUPROFEN
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA090796
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameIBUPROFEN
Active Ingredient Strength400 mg/1
Pharm ClassesCyclooxygenase
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-872-06

6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-06)
Marketing Start Date2019-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-872-20 [43063087220]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-07

NDC 43063-872-90 [43063087290]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-26

NDC 43063-872-82 [43063087282]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-02

NDC 43063-872-40 [43063087240]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-07

NDC 43063-872-10 [43063087210]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-29

NDC 43063-872-30 [43063087230]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-07

NDC 43063-872-06 [43063087206]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-25

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN400 mg/1

OpenFDA Data

SPL SET ID:ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197805
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0343063872406
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.