NDC 57664-120

INDOMETHACIN

Indomethacin

INDOMETHACIN is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Caraco Pharmaceutical Laboratories, Ltd.. The primary component is Indomethacin.

Product ID57664-120_45ad5425-58bc-46b3-8f6e-c01f4dd1d1e7
NDC57664-120
Product TypeHuman Prescription Drug
Proprietary NameINDOMETHACIN
Generic NameIndomethacin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-05-16
Marketing CategoryANDA / ANDA
Application NumberANDA091401
Labeler NameCaraco Pharmaceutical Laboratories, 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 57664-120-08

100 CAPSULE in 1 BOTTLE (57664-120-08)
Marketing Start Date2013-05-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-120-08 [57664012008]

INDOMETHACIN CAPSULE
Marketing CategoryANDA
Application NumberANDA091401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-16
Inactivation Date2019-11-27

NDC 57664-120-88 [57664012088]

INDOMETHACIN CAPSULE
Marketing CategoryANDA
Application NumberANDA091401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-16
Inactivation Date2019-11-27

NDC 57664-120-13 [57664012013]

INDOMETHACIN CAPSULE
Marketing CategoryANDA
Application NumberANDA091401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-16
Inactivation Date2019-11-27

NDC 57664-120-18 [57664012018]

INDOMETHACIN CAPSULE
Marketing CategoryANDA
Application NumberANDA091401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-16
Inactivation Date2019-11-27

NDC 57664-120-83 [57664012083]

INDOMETHACIN CAPSULE
Marketing CategoryANDA
Application NumberANDA091401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-05-16
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN50 mg/1

OpenFDA Data

SPL SET ID:c70b5045-706e-443a-9be1-d0bc3c598130
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197817
  • 197818
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0357664119884
  • 0357664120088
    • 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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