NDC 43063-858

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 ID43063-858_8414b1f0-7125-f8e9-e053-2991aa0a7b27
NDC43063-858
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 Strength800 mg/1
Pharm ClassesCyclooxygenase
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-858-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-858-01)
Marketing Start Date2019-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-858-01 [43063085801]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-03

NDC 43063-858-60 [43063085860]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-18 [43063085818]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-15 [43063085815]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-21 [43063085821]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-20

NDC 43063-858-04 [43063085804]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-22

NDC 43063-858-06 [43063085806]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-04

NDC 43063-858-12 [43063085812]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-90 [43063085890]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-82 [43063085882]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-24

NDC 43063-858-24 [43063085824]

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

NDC 43063-858-94 [43063085894]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-30 [43063085830]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-10 [43063085810]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-06

NDC 43063-858-28 [43063085828]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-24

NDC 43063-858-20 [43063085820]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-21

NDC 43063-858-09 [43063085809]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-20

NDC 43063-858-93 [43063085893]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-08

NDC 43063-858-40 [43063085840]

IBUPROFEN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-03

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:eb2f349f-1731-4d1d-8218-fff6f6850091
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197807
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0343063858158
    • 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
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