NDC 59746-379

Indomethacin extended-release

Indomethacin Extended-release

Indomethacin extended-release is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Jubilant Cadista Pharmaceuticals Inc.. The primary component is Indomethacin.

Product ID59746-379_7275b33f-ac32-4f0f-832c-22077e2edc5e
NDC59746-379
Product TypeHuman Prescription Drug
Proprietary NameIndomethacin extended-release
Generic NameIndomethacin Extended-release
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-10-05
Marketing CategoryANDA / ANDA
Application NumberANDA202706
Labeler NameJubilant Cadista Pharmaceuticals Inc.
Substance NameINDOMETHACIN
Active Ingredient Strength75 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59746-379-01

100 CAPSULE in 1 BOTTLE (59746-379-01)
Marketing Start Date2015-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59746-379-01 [59746037901]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-05

NDC 59746-379-60 [59746037960]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-05

NDC 59746-379-90 [59746037990]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-05

NDC 59746-379-05 [59746037905]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-05

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN75 mg/1

OpenFDA Data

SPL SET ID:7b61c038-717c-0dee-4cab-d6aa55cbf28a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310992
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0359746379056
  • 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]

    Medicade Reported Pricing

    59746037990 INDOMETHACIN ER 75 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    59746037960 INDOMETHACIN ER 75 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Indomethacin extended-release" or generic name "Indomethacin Extended-release"

    NDCBrand NameGeneric Name
    52959-082INDOMETHACIN EXTENDED-RELEASEINDOMETHACIN EXTENDED-RELEASE
    59746-379Indomethacin extended-releaseIndomethacin extended-release
    65862-684Indomethacin Extended-ReleaseIndomethacin Extended-Release
    68071-3174Indomethacin extended-releaseIndomethacin extended-release
    68387-345Indomethacin extended-releaseIndomethacin extended-release
    71335-0137Indomethacin extended-releaseIndomethacin extended-release

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