indomethacin

Generic: indomethacin

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

indomethacin 25 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-148
Product ID 76420-148_e49badcf-439d-5511-e053-2995a90a14bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091240
Listing Expiration 2026-12-31
Marketing Start 2016-05-19

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 76420148
Hyphenated Format 76420-148

Supplemental Identifiers

RxCUI
197817
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
  • 25 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE (76420-148-14)
  • 20 CAPSULE in 1 BOTTLE (76420-148-20)
  • 30 CAPSULE in 1 BOTTLE (76420-148-30)
  • 60 CAPSULE in 1 BOTTLE (76420-148-60)
  • 90 CAPSULE in 1 BOTTLE (76420-148-90)
source: ndc

Packages (5)

76420-148-14 14 CAPSULE in 1 BOTTLE (76420-148-14) 76420-148-20 20 CAPSULE in 1 BOTTLE (76420-148-20) 76420-148-30 30 CAPSULE in 1 BOTTLE (76420-148-30) 76420-148-60 60 CAPSULE in 1 BOTTLE (76420-148-60) 76420-148-90 90 CAPSULE in 1 BOTTLE (76420-148-90)

Ingredients (1)

indomethacin (25 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": "e49badcf-439d-5511-e053-2995a90a14bf", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["197817"], "spl_set_id": ["9c15102c-b6f9-4198-b592-152160591014"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE (76420-148-14)", "package_ndc": "76420-148-14", "marketing_start_date": "20220725"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-148-20)", "package_ndc": "76420-148-20", "marketing_start_date": "20220725"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-148-30)", "package_ndc": "76420-148-30", "marketing_start_date": "20220725"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-148-60)", "package_ndc": "76420-148-60", "marketing_start_date": "20220725"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-148-90)", "package_ndc": "76420-148-90", "marketing_start_date": "20220725"}], "brand_name": "Indomethacin", "product_id": "76420-148_e49badcf-439d-5511-e053-2995a90a14bf", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-148", "generic_name": "Indomethacin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "25 mg/1"}], "application_number": "ANDA091240", "marketing_category": "ANDA", "marketing_start_date": "20160519", "listing_expiration_date": "20261231"}