indomethacin

Generic: indomethacin

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

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

indomethacin 75 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-325
Product ID 68462-325_e729f88c-b2c8-4462-98be-7184de95b01d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203501
Listing Expiration 2026-12-31
Marketing Start 2017-06-22

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 68462325
Hyphenated Format 68462-325

Supplemental Identifiers

RxCUI
310992
UPC
0368462325605
UNII
XXE1CET956
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

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 ANDA203501 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-10)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-60)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-90)
source: ndc

Packages (5)

68462-325-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01) 68462-325-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05) 68462-325-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-10) 68462-325-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-60) 68462-325-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-90)

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": "e729f88c-b2c8-4462-98be-7184de95b01d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368462325605"], "unii": ["XXE1CET956"], "rxcui": ["310992"], "spl_set_id": ["532d40b2-c05c-4d4f-b7ee-e6434c4c27fc"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01)", "package_ndc": "68462-325-01", "marketing_start_date": "20170622"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05)", "package_ndc": "68462-325-05", "marketing_start_date": "20170622"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-10)", "package_ndc": "68462-325-10", "marketing_start_date": "20170622"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-60)", "package_ndc": "68462-325-60", "marketing_start_date": "20170622"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-90)", "package_ndc": "68462-325-90", "marketing_start_date": "20170622"}], "brand_name": "indomethacin", "product_id": "68462-325_e729f88c-b2c8-4462-98be-7184de95b01d", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68462-325", "generic_name": "indomethacin", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "75 mg/1"}], "application_number": "ANDA203501", "marketing_category": "ANDA", "marketing_start_date": "20170622", "listing_expiration_date": "20261231"}