indomethacin

Generic: indomethacin

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

indomethacin 75 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-506
Product ID 65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091549
Listing Expiration 2026-12-31
Marketing Start 2010-12-06

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 65162506
Hyphenated Format 65162-506

Supplemental Identifiers

RxCUI
310992
UPC
0365162506105
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 ANDA091549 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09)
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50)
source: ndc

Packages (6)

65162-506-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03) 65162-506-06 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06) 65162-506-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09) 65162-506-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10) 65162-506-11 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11) 65162-506-50 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50)

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": "083ef389-551a-48c5-9a92-f16fb6270ae4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0365162506105"], "unii": ["XXE1CET956"], "rxcui": ["310992"], "spl_set_id": ["dbad7e61-2347-43b1-a422-9183e41c10ea"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03)", "package_ndc": "65162-506-03", "marketing_start_date": "20101206"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06)", "package_ndc": "65162-506-06", "marketing_start_date": "20101206"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09)", "package_ndc": "65162-506-09", "marketing_start_date": "20101206"}, {"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10)", "package_ndc": "65162-506-10", "marketing_start_date": "20101206"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11)", "package_ndc": "65162-506-11", "marketing_start_date": "20101206"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50)", "package_ndc": "65162-506-50", "marketing_start_date": "20101206"}], "brand_name": "Indomethacin", "product_id": "65162-506_083ef389-551a-48c5-9a92-f16fb6270ae4", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "65162-506", "generic_name": "Indomethacin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "75 mg/1"}], "application_number": "ANDA091549", "marketing_category": "ANDA", "marketing_start_date": "20101206", "listing_expiration_date": "20261231"}