NDC 65162-506

Indomethacin

Indomethacin

Indomethacin is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Indomethacin.

Product ID65162-506_0bddc5bb-95a8-4e9d-b4fc-077a140397a5
NDC65162-506
Product TypeHuman Prescription Drug
Proprietary NameIndomethacin
Generic NameIndomethacin
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-12-06
Marketing CategoryANDA / ANDA
Application NumberANDA091549
Labeler NameAmneal Pharmaceuticals LLC
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 65162-506-03

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)
Marketing Start Date2010-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-506-06 [65162050606]

Indomethacin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-06

NDC 65162-506-10 [65162050610]

Indomethacin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091549
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-06

NDC 65162-506-03 [65162050603]

Indomethacin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-06

NDC 65162-506-11 [65162050611]

Indomethacin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091549
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-06

NDC 65162-506-09 [65162050609]

Indomethacin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-06

NDC 65162-506-50 [65162050650]

Indomethacin CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-06

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN75 mg/1

OpenFDA Data

SPL SET ID:dbad7e61-2347-43b1-a422-9183e41c10ea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310992
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0365162506105
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

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

    Medicade Reported Pricing

    65162050650 INDOMETHACIN ER 75 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    65162050609 INDOMETHACIN ER 75 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    65162050606 INDOMETHACIN ER 75 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    65162050603 INDOMETHACIN ER 75 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Indomethacin" or generic name "Indomethacin"

    NDCBrand NameGeneric Name
    0185-0720IndomethacinIndomethacin
    0378-0143Indomethacinindomethacin
    0378-0147Indomethacinindomethacin
    0409-1113IndomethacinIndomethacin
    0440-1652Indomethacinindomethacin
    0713-0176INDOMETHACININDOMETHACIN
    10544-083IndomethacinIndomethacin
    10544-216Indomethacinindomethacin
    10544-234Indomethacinindomethacin
    10544-919IndomethacinIndomethacin
    10544-935IndomethacinIndomethacin
    10702-016INDOMETHACINIndomethacin
    21695-522IndomethacinIndomethacin
    21695-523IndomethacinIndomethacin
    23155-010IndomethacinIndomethacin
    23155-011IndomethacinIndomethacin
    31722-542IndomethacinIndomethacin
    31722-543IndomethacinIndomethacin
    31722-565IndomethacinIndomethacin
    33261-133Indomethacinindomethacin
    35356-697IndomethacinIndomethacin
    42254-081IndomethacinIndomethacin
    42254-237INDOMETHACINindomethacin
    42708-030indomethacinindomethacin
    43063-368IndomethacinIndomethacin
    68071-3060IndomethacinIndomethacin
    68071-3277IndomethacinIndomethacin
    68071-4091indomethacinindomethacin
    68071-4394IndomethacinIndomethacin
    68084-411IndomethacinIndomethacin
    68151-0279IndomethacinIndomethacin
    68151-2919IndomethacinIndomethacin
    68151-1733INDOMETHACININDOMETHACIN
    68382-293indomethacinindomethacin
    68382-294indomethacinindomethacin
    68382-371indomethacinindomethacin
    68382-470INDOMETHACININDOMETHACIN
    68462-302IndomethacinIndomethacin
    68462-325indomethacinindomethacin
    68462-406IndomethacinIndomethacin
    68788-6448IndomethacinIndomethacin
    68788-6983IndomethacinIndomethacin
    68788-6821IndomethacinIndomethacin
    68788-9107INDOMETHACININDOMETHACIN
    68788-9108INDOMETHACININDOMETHACIN
    70518-0254IndomethacinIndomethacin
    70518-0515IndomethacinIndomethacin
    70518-1458IndomethacinIndomethacin
    70518-1512IndomethacinIndomethacin
    70771-1203indomethacinindomethacin
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.