Approvals (Drugs@FDA)

INDOMETHACIN

AMNEAL · INDOMETHACIN

ANDA215399Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA215399
Sponsor name
AMNEAL
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250224
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    INDOMETHACIN
    Reference standard
    No
    Dosage form
    SUPPOSITORY
    Route
    RECTAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      INDOMETHACIN
      Strength
      50MG
Harmonized identifiers (openFDA)
Application number
ANDA215399
Brand name
INDOMETHACIN
Generic name
INDOMETHACIN
Manufacturer name
Amneal Pharmaceuticals NY LLC
Product NDC
69238-2086
Product type
HUMAN PRESCRIPTION DRUG
Route
RECTAL
Substance name
INDOMETHACIN
RxCUI
197819
SPL ID
46b85569-0280-40b8-8230-939ec20c8c1a
SPL set ID
8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a
Package NDC
69238-2086-3
Nui
N0000000160, M0001335, N0000175722
Pharm class moa
Cyclooxygenase Inhibitors [MoA]
Pharm class cs
Anti-Inflammatory Agents, Non-Steroidal [CS]
Pharm class epc
Nonsteroidal Anti-inflammatory Drug [EPC]
UNII
XXE1CET956
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.