NDC 69344-101

Indocin

Indomethacin

Indocin is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Egalet Us Inc.. The primary component is Indomethacin.

Product ID69344-101_30b35ff4-5592-47d1-815f-7c727c5fbf1f
NDC69344-101
Product TypeHuman Prescription Drug
Proprietary NameIndocin
Generic NameIndomethacin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-02-04
Marketing CategoryNDA / NDA
Application NumberNDA018332
Labeler NameEgalet US Inc.
Substance NameINDOMETHACIN
Active Ingredient Strength25 mg/5mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69344-101-01

1 BOTTLE, GLASS in 1 CARTON (69344-101-01) > 237 mL in 1 BOTTLE, GLASS
Marketing Start Date2019-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69344-101-01 [69344010101]

Indocin SUSPENSION
Marketing CategoryNDA
Application NumberNDA018332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-04

Drug Details

Active Ingredients

IngredientStrength
INDOMETHACIN25 mg/5mL

OpenFDA Data

SPL SET ID:73878376-1d24-423b-9f37-3666e83c95da
Manufacturer
UNII
PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0369344101010
    • 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 "Indocin" or generic name "Indomethacin"

    NDCBrand NameGeneric Name
    42211-101INDOCINindomethacin
    42211-102INDOCINIndomethacin
    69344-101IndocinIndocin
    69344-102INDOCININDOCIN
    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
    12634-160INDOMETHACIN ERINDOMETHACIN
    12634-838INDOMETHACIN ERINDOMETHACIN
    42211-201Tivorbexindomethacin
    42211-202Tivorbexindomethacin

    Trademark Results [Indocin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    INDOCIN
    INDOCIN
    73445422 not registered Dead/Abandoned
    Merck & Co., Inc.
    1983-09-26
    INDOCIN
    INDOCIN
    72159596 0758725 Live/Registered
    MERCK & CO., INC.
    1962-12-21
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