NDC 53345-014

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. The primary component is Ibuprofen.

Product ID53345-014_1d47d7ef-372d-43a8-bf66-e1c6c81e3da1
NDC53345-014
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-10-06
Marketing CategoryANDA / ANDA
Application NumberANDA206568
Labeler NameHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-014-01

1 BAG in 1 BOX (53345-014-01) > 10000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2016-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-014-02 [53345001402]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-13

NDC 53345-014-01 [53345001401]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-06

NDC 53345-014-04 [53345001404]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-14
Marketing End Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:f24ddc6d-a2af-4428-9e2a-eaa4c3865130
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310964
    • 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
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