indomethacin

Generic: indomethacin

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler hikma pharmaceuticals usa inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

indomethacin 50 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-1950
Product ID 0054-1950_536da97c-1c9d-4cf8-ae7a-a263cc59c8e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215899
Listing Expiration 2026-12-31
Marketing Start 2024-11-20

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 00541950
Hyphenated Format 0054-1950

Supplemental Identifiers

RxCUI
197819
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 ANDA215899 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 SUPPOSITORY in 1 BOX (0054-1950-30)
source: ndc

Packages (1)

0054-1950-30 30 SUPPOSITORY in 1 BOX (0054-1950-30)

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": "536da97c-1c9d-4cf8-ae7a-a263cc59c8e6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["197819"], "spl_set_id": ["2033059b-4be1-42d0-b888-34d8202f3e09"], "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": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 SUPPOSITORY in 1 BOX (0054-1950-30)", "package_ndc": "0054-1950-30", "marketing_start_date": "20241120"}], "brand_name": "INDOMETHACIN", "product_id": "0054-1950_536da97c-1c9d-4cf8-ae7a-a263cc59c8e6", "dosage_form": "SUPPOSITORY", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0054-1950", "generic_name": "Indomethacin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INDOMETHACIN", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "50 mg/1"}], "application_number": "ANDA215899", "marketing_category": "ANDA", "marketing_start_date": "20241120", "listing_expiration_date": "20261231"}