indomethacin

Generic: indomethacin

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

indomethacin 50 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-431
Product ID 50268-431_2e099c64-82cd-0174-e063-6394a90a5207
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091240
Listing Expiration 2026-12-31
Marketing Start 2015-05-20

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 50268431
Hyphenated Format 50268-431

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 ANDA091240 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-431-15) / 1 CAPSULE in 1 BLISTER PACK (50268-431-11)
source: ndc

Packages (1)

50268-431-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-431-15) / 1 CAPSULE in 1 BLISTER PACK (50268-431-11)

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": "2e099c64-82cd-0174-e063-6394a90a5207", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["197817", "197818"], "spl_set_id": ["bcaa0e51-a2fc-cf74-027a-1964e38c5e4e"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-431-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-431-11)", "package_ndc": "50268-431-15", "marketing_start_date": "20150520"}], "brand_name": "Indomethacin", "product_id": "50268-431_2e099c64-82cd-0174-e063-6394a90a5207", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50268-431", "generic_name": "Indomethacin", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "50 mg/1"}], "application_number": "ANDA091240", "marketing_category": "ANDA", "marketing_start_date": "20150520", "listing_expiration_date": "20261231"}