indomethacin

Generic: indomethacin

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler amneal pharmaceuticals ny llc
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

indomethacin 50 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2086
Product ID 69238-2086_46b85569-0280-40b8-8230-939ec20c8c1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215399
Listing Expiration 2026-12-31
Marketing Start 2025-02-26

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382086
Hyphenated Format 69238-2086

Supplemental Identifiers

RxCUI
197819
UPC
0369238208634
UNII
XXE1CET956
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name indomethacin (source: ndc)
Generic Name indomethacin (source: ndc)
Application Number ANDA215399 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 SUPPOSITORY in 1 BOX (69238-2086-3)
source: ndc

Packages (1)

69238-2086-3 30 SUPPOSITORY in 1 BOX (69238-2086-3)

Ingredients (1)

indomethacin (50 mg/1)

Linked Drug Pages (1)

Indomethacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "46b85569-0280-40b8-8230-939ec20c8c1a", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0369238208634"], "unii": ["XXE1CET956"], "rxcui": ["197819"], "spl_set_id": ["8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 SUPPOSITORY in 1 BOX (69238-2086-3)", "package_ndc": "69238-2086-3", "marketing_start_date": "20250226"}], "brand_name": "Indomethacin", "product_id": "69238-2086_46b85569-0280-40b8-8230-939ec20c8c1a", "dosage_form": "SUPPOSITORY", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69238-2086", "generic_name": "Indomethacin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "50 mg/1"}], "application_number": "ANDA215399", "marketing_category": "ANDA", "marketing_start_date": "20250226", "listing_expiration_date": "20261231"}