NDC 68382-470

INDOMETHACIN

Indomethacin

INDOMETHACIN is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Indomethacin Sodium.

Product ID68382-470_37cff808-1732-462d-857b-6173382e5cba
NDC68382-470
Product TypeHuman Prescription Drug
Proprietary NameINDOMETHACIN
Generic NameIndomethacin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA206561
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameINDOMETHACIN SODIUM
Active Ingredient Strength1 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-470-01

1 VIAL in 1 CARTON (68382-470-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2021-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-470-01 [68382047001]

INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206561
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-03

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN SODIUM1 mg/1

OpenFDA Data

SPL SET ID:febe47c6-8fbe-4f6f-8ad1-6daf30c96bc3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 346508
  • UPC Code
  • 0368382470010
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    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

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