NDC 65862-684

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 Aurobindo Pharma Limited. The primary component is Indomethacin.

Product ID65862-684_16509c6f-ff5c-4a20-b94a-c5474a13275a
NDC65862-684
Product TypeHuman Prescription Drug
Proprietary NameIndomethacin Extended-Release
Generic NameIndomethacin Extended-release
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-12-27
Marketing CategoryANDA / ANDA
Application NumberANDA204243
Labeler NameAurobindo Pharma Limited
Substance NameINDOMETHACIN
Active Ingredient Strength75 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65862-684-01

100 CAPSULE in 1 BOTTLE (65862-684-01)
Marketing Start Date2016-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-684-60 [65862068460]

Indomethacin Extended-Release CAPSULE
Marketing CategoryANDA
Application NumberANDA204243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-27

NDC 65862-684-01 [65862068401]

Indomethacin Extended-Release CAPSULE
Marketing CategoryANDA
Application NumberANDA204243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-27

NDC 65862-684-99 [65862068499]

Indomethacin Extended-Release CAPSULE
Marketing CategoryANDA
Application NumberANDA204243
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-27

NDC 65862-684-05 [65862068405]

Indomethacin Extended-Release CAPSULE
Marketing CategoryANDA
Application NumberANDA204243
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-27

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN75 mg/1

OpenFDA Data

SPL SET ID:16509c6f-ff5c-4a20-b94a-c5474a13275a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310992
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0365862684608
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    Medicade Reported Pricing

    65862068460 INDOMETHACIN ER 75 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    65862068401 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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