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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

indomethacin 75 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-029
Product ID 76420-029_ead13cff-b9d2-cdc1-e053-2a95a90adf09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201807
Listing Expiration 2026-12-31
Marketing Start 2015-07-24

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 76420029
Hyphenated Format 76420-029

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 (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
  • 1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-01)
  • 2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-02)
  • 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-07)
  • 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-14)
source: ndc

Packages (4)

76420-029-01 1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-01) 76420-029-02 2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-02) 76420-029-07 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-07) 76420-029-14 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-14)

Ingredients (1)

indomethacin (75 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": "ead13cff-b9d2-cdc1-e053-2a95a90adf09", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["310992"], "spl_set_id": ["dfdcdb27-07a0-47e6-b8da-d9c99045a066"], "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": "1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-01)", "package_ndc": "76420-029-01", "marketing_start_date": "20200211"}, {"sample": false, "description": "2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-02)", "package_ndc": "76420-029-02", "marketing_start_date": "20200211"}, {"sample": false, "description": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-07)", "package_ndc": "76420-029-07", "marketing_start_date": "20200211"}, {"sample": false, "description": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-14)", "package_ndc": "76420-029-14", "marketing_start_date": "20200211"}], "brand_name": "Indomethacin", "product_id": "76420-029_ead13cff-b9d2-cdc1-e053-2a95a90adf09", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-029", "generic_name": "Indomethacin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "75 mg/1"}], "application_number": "ANDA201807", "marketing_category": "ANDA", "marketing_start_date": "20150724", "listing_expiration_date": "20261231"}