indomethacin

Generic: indomethacin

Labeler: sportpharm llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

indomethacin 75 mg/1

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-034
Product ID 85766-034_4a2b8c6c-d4d6-6810-e063-6394a90ab709
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201807
Listing Expiration 2027-12-31
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 85766034
Hyphenated Format 85766-034

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 (85766-034-01)
  • 2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-02)
  • 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-07)
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-10)
  • 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-14)
  • 20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-20)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-30)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-60)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-90)
source: ndc

Packages (9)

85766-034-01 1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-01) 85766-034-02 2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-02) 85766-034-07 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-07) 85766-034-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-10) 85766-034-14 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-14) 85766-034-20 20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-20) 85766-034-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-30) 85766-034-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-60) 85766-034-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-90)

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": "4a2b8c6c-d4d6-6810-e063-6394a90ab709", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["310992"], "spl_set_id": ["12821a3a-b5f2-4415-84c9-0a30a4725f1e"], "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": ["Sportpharm LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-01)", "package_ndc": "85766-034-01", "marketing_start_date": "20250807"}, {"sample": false, "description": "2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-02)", "package_ndc": "85766-034-02", "marketing_start_date": "20250807"}, {"sample": false, "description": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-07)", "package_ndc": "85766-034-07", "marketing_start_date": "20250807"}, {"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-10)", "package_ndc": "85766-034-10", "marketing_start_date": "20250807"}, {"sample": false, "description": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-14)", "package_ndc": "85766-034-14", "marketing_start_date": "20250807"}, {"sample": false, "description": "20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-20)", "package_ndc": "85766-034-20", "marketing_start_date": "20250807"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-30)", "package_ndc": "85766-034-30", "marketing_start_date": "20250807"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-60)", "package_ndc": "85766-034-60", "marketing_start_date": "20250807"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85766-034-90)", "package_ndc": "85766-034-90", "marketing_start_date": "20250807"}], "brand_name": "Indomethacin", "product_id": "85766-034_4a2b8c6c-d4d6-6810-e063-6394a90ab709", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "85766-034", "generic_name": "Indomethacin", "labeler_name": "Sportpharm LLC", "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": "20271231"}