NDC 51013-103

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc. The primary component is Ibuprofen.

Product ID51013-103_82b77390-3308-4b92-8b69-42dd6c0c2b4c
NDC51013-103
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-10-12
Marketing CategoryANDA / ANDA
Application NumberANDA206568
Labeler NamePuraCap Pharmaceutical LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51013-103-15

1 BOTTLE, PLASTIC in 1 CARTON (51013-103-15) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date2016-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-103-39 [51013010339]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-103-15 [51013010315]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-103-29 [51013010329]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-103-63 [51013010363]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-17

NDC 51013-103-41 [51013010341]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-16

NDC 51013-103-26 [51013010326]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-103-42 [51013010342]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-16

NDC 51013-103-28 [51013010328]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-103-38 [51013010338]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-103-25 [51013010325]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-103-22 [51013010322]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-16

NDC 51013-103-31 [51013010331]

Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206568
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:67e09ad5-e010-4aa1-b86e-9b22331bf33b
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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