indomethacin er

Generic: indomethacin

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin er
Generic Name indomethacin
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

indomethacin 75 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0271
Product ID 80425-0271_2a9bad62-b300-697c-e063-6294a90aa395
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201807
Listing Expiration 2026-12-31
Marketing Start 2023-02-17

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 804250271
Hyphenated Format 80425-0271

Supplemental Identifiers

RxCUI
310992
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 er (source: ndc)
Generic Name indomethacin (source: ndc)
Application Number ANDA201807 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0271-1)
source: ndc

Packages (1)

80425-0271-1 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0271-1)

Ingredients (1)

indomethacin (75 mg/1)

Linked Drug Pages (1)

Indomethacin ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a9bad62-b300-697c-e063-6294a90aa395", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["310992"], "spl_set_id": ["f4e8a719-ef9c-a2ef-e053-2995a90ad788"], "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": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0271-1)", "package_ndc": "80425-0271-1", "marketing_start_date": "20230217"}], "brand_name": "Indomethacin ER", "product_id": "80425-0271_2a9bad62-b300-697c-e063-6294a90aa395", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "80425-0271", "generic_name": "Indomethacin", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "brand_name_suffix": "ER", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "75 mg/1"}], "application_number": "ANDA201807", "marketing_category": "ANDA", "marketing_start_date": "20230217", "listing_expiration_date": "20261231"}