NDC 68071-3174

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 Nucare Pharmaceuticals, Inc.. The primary component is Indomethacin.

Product ID68071-3174_4af33646-6054-6245-e054-00144ff88e88
NDC68071-3174
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 NameNuCare 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 Through2019-12-31

Packaging

NDC 68071-3174-6

60 CAPSULE in 1 BOTTLE (68071-3174-6)
Marketing Start Date2017-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3174-2 [68071317402]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-17
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-07

NDC 68071-3174-3 [68071317403]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-17
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-07

NDC 68071-3174-5 [68071317405]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-17
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-07

NDC 68071-3174-6 [68071317406]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-17
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-07

NDC 68071-3174-7 [68071317407]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-17
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-07

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN75 mg/1

OpenFDA Data

SPL SET ID:4af33646-6052-6245-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310992
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • 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]

    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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