NDC 68210-8100

Ibuprofen

Ibuprofen

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

Product ID68210-8100_a0aeb74b-a0f3-da0c-e053-2995a90a9d77
NDC68210-8100
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-03-10
Marketing CategoryANDA / ANDA
Application NumberANDA079174
Labeler NameSpirit Pharmaceutical LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68210-8100-2

1 BOTTLE in 1 CARTON (68210-8100-2) > 25 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2020-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-8100-3 [68210810003]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079174
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-10

NDC 68210-8100-5 [68210810005]

Ibuprofen TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079174
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-10

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:a96d012e-b132-4e99-b84b-ccd3a9a05cbb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • 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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