NDC 12634-160

INDOMETHACIN ER

Indomethacin

INDOMETHACIN ER is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Apotheca, Inc.. The primary component is Indomethacin.

Product ID12634-160_543aa8e5-219e-41d8-8ffa-9ae1446d3391
NDC12634-160
Product TypeHuman Prescription Drug
Proprietary NameINDOMETHACIN ER
Generic NameIndomethacin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-03-04
Marketing CategoryANDA / ANDA
Application NumberANDA079175
Labeler NameApotheca, Inc.
Substance NameINDOMETHACIN
Active Ingredient Strength75 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 12634-160-85

15 CAPSULE in 1 BOTTLE, PLASTIC (12634-160-85)
Marketing Start Date2010-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-160-54 [12634016054]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-79 [12634016079]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-60 [12634016060]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-00 [12634016000]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-57 [12634016057]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-59 [12634016059]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-85 [12634016085]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-25 [12634016025]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-91 [12634016091]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-55 [12634016055]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-97 [12634016097]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-84 [12634016084]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-71 [12634016071]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

NDC 12634-160-80 [12634016080]

INDOMETHACIN ER CAPSULE
Marketing CategoryANDA
Application NumberANDA079175
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN75 mg/1

OpenFDA Data

SPL SET ID:6569dfd1-0164-4241-b508-ccd540d1e858
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310992
    • 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]

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

    NDCBrand NameGeneric Name
    12634-160INDOMETHACIN ERINDOMETHACIN
    12634-838INDOMETHACIN ERINDOMETHACIN
    42211-101INDOCINindomethacin
    42211-102INDOCINIndomethacin
    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
    42211-201Tivorbexindomethacin
    42211-202Tivorbexindomethacin
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