NDC 63323-659

Indomethacin

Indomethacin

Indomethacin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Indomethacin.

Product ID63323-659_0c949659-628e-444e-8b9d-b09d7067d274
NDC63323-659
Product TypeHuman Prescription Drug
Proprietary NameIndomethacin
Generic NameIndomethacin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-03-19
Marketing CategoryNDA / NDA
Application NumberNDA022536
Labeler NameFresenius Kabi USA, LLC
Substance NameINDOMETHACIN
Active Ingredient Strength1 mg/mL
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 63323-659-09

1 VIAL in 1 CARTON (63323-659-09) > 1 mL in 1 VIAL
Marketing Start Date2010-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-659-03 [63323065903]

Indomethacin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022536
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-19

NDC 63323-659-09 [63323065909]

Indomethacin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022536
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-19

NDC 63323-659-94 [63323065994]

Indomethacin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022536
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-19

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN1 mg/mL

OpenFDA Data

SPL SET ID:dd5caa3f-3c09-4034-bf43-2df80c61c07b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 346508
  • 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" 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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