NDC 71335-0137

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 Bryant Ranch Prepack. The primary component is Indomethacin.

Product ID71335-0137_3e51d610-e593-45e4-8776-b00340f05e7f
NDC71335-0137
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 NameBryant Ranch Prepack
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 Through2022-12-31

Packaging

NDC 71335-0137-1

30 CAPSULE in 1 BOTTLE (71335-0137-1)
Marketing Start Date2017-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0137-8 [71335013708]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

NDC 71335-0137-4 [71335013704]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

NDC 71335-0137-5 [71335013705]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

NDC 71335-0137-6 [71335013706]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

NDC 71335-0137-3 [71335013703]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

NDC 71335-0137-2 [71335013702]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

NDC 71335-0137-7 [71335013707]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

NDC 71335-0137-1 [71335013701]

Indomethacin extended-release CAPSULE
Marketing CategoryANDA
Application NumberANDA202706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN75 mg/1

OpenFDA Data

SPL SET ID:57212c49-c54a-4c55-8875-122a01fbb08f
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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