NDC 53746-137

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Ibuprofen.

Product ID53746-137_13ff51be-c90c-4936-9f1f-809f8f5ac641
NDC53746-137
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA071935
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameIBUPROFEN
Active Ingredient Strength800 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 53746-137-01

100 TABLET in 1 BOTTLE (53746-137-01)
Marketing Start Date2009-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53746-137-30 [53746013730]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA071935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05

NDC 53746-137-60 [53746013760]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA071935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05

NDC 53746-137-90 [53746013790]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA071935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05

NDC 53746-137-01 [53746013701]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA071935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05

NDC 53746-137-50 [53746013750]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA071935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05

NDC 53746-137-05 [53746013705]

Ibuprofen TABLET
Marketing CategoryANDA
Application NumberANDA071935
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-05

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:75d963b9-3675-44ff-bc6b-83461bed1b67
Manufacturer
UNII
PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0353746137012
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • 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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