indomethacin

Generic: indomethacin

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler direct rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

indomethacin 50 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 61919-164
Product ID 61919-164_151f8422-70b3-cf70-e063-6294a90a90fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091276
Listing Expiration 2026-12-31
Marketing Start 2017-04-20

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 61919164
Hyphenated Format 61919-164

Supplemental Identifiers

RxCUI
197817 197818
UNII
XXE1CET956
NUI
N0000000160 M0001335 N0000175722

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 ANDA091276 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 21 CAPSULE in 1 BOTTLE (61919-164-21)
  • 30 CAPSULE in 1 BOTTLE (61919-164-30)
source: ndc

Packages (2)

61919-164-21 21 CAPSULE in 1 BOTTLE (61919-164-21) 61919-164-30 30 CAPSULE in 1 BOTTLE (61919-164-30)

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": ["ORAL"], "spl_id": "151f8422-70b3-cf70-e063-6294a90a90fb", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["197817", "197818"], "spl_set_id": ["4d9a253a-f014-4fab-e054-00144ff8d46c"], "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": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BOTTLE (61919-164-21)", "package_ndc": "61919-164-21", "marketing_start_date": "20170420"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (61919-164-30)", "package_ndc": "61919-164-30", "marketing_start_date": "20170420"}], "brand_name": "INDOMETHACIN", "product_id": "61919-164_151f8422-70b3-cf70-e063-6294a90a90fb", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "61919-164", "generic_name": "INDOMETHACIN", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INDOMETHACIN", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "50 mg/1"}], "application_number": "ANDA091276", "marketing_category": "ANDA", "marketing_start_date": "20170420", "listing_expiration_date": "20261231"}