NDC 65977-5043

Indomethacin

Indomethacin

Indomethacin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Hetero Drugs Ltd.,. The primary component is Indomethacin.

Product ID65977-5043_110aada7-dfe8-4ecf-80c7-4dac8907ad29
NDC65977-5043
Product TypeHuman Prescription Drug
Proprietary NameIndomethacin
Generic NameIndomethacin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA091240
Labeler NameHetero Drugs Ltd.,
Substance NameINDOMETHACIN
Active Ingredient Strength50 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65977-5043-3

1000 CAPSULE in 1 BOTTLE (65977-5043-3)
Marketing Start Date2011-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65977-5043-0 [65977504300]

Indomethacin CAPSULE
Marketing CategoryANDA
Application NumberANDA091240
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-12
Inactivation Date2019-10-29

NDC 65977-5043-2 [65977504302]

Indomethacin CAPSULE
Marketing CategoryANDA
Application NumberANDA091240
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-12
Inactivation Date2019-10-29

NDC 65977-5043-1 [65977504301]

Indomethacin CAPSULE
Marketing CategoryANDA
Application NumberANDA091240
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-12
Inactivation Date2019-10-29

NDC 65977-5043-3 [65977504303]

Indomethacin CAPSULE
Marketing CategoryANDA
Application NumberANDA091240
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-12
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN50 mg/1

OpenFDA Data

SPL SET ID:110aada7-dfe8-4ecf-80c7-4dac8907ad29
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197817
  • 197818
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0365977504204
  • 0365977504303
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

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