indomethacin

Generic: indomethacin

Labeler: xlcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler xlcare pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

indomethacin 25 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-148
Product ID 72865-148_f26f7451-69b2-99d7-e053-2a95a90af7a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091240
Listing Expiration 2026-12-31
Marketing Start 2021-07-27

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 72865148
Hyphenated Format 72865-148

Supplemental Identifiers

RxCUI
197817 197818
UPC
0372865148013 0372865149010
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 ANDA091240 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (72865-148-01)
  • 500 CAPSULE in 1 BOTTLE (72865-148-05)
  • 1000 CAPSULE in 1 BOTTLE (72865-148-10)
  • 30 CAPSULE in 1 BOTTLE (72865-148-30)
source: ndc

Packages (4)

72865-148-01 100 CAPSULE in 1 BOTTLE (72865-148-01) 72865-148-05 500 CAPSULE in 1 BOTTLE (72865-148-05) 72865-148-10 1000 CAPSULE in 1 BOTTLE (72865-148-10) 72865-148-30 30 CAPSULE in 1 BOTTLE (72865-148-30)

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": "f26f7451-69b2-99d7-e053-2a95a90af7a1", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0372865148013", "0372865149010"], "unii": ["XXE1CET956"], "rxcui": ["197817", "197818"], "spl_set_id": ["bc8a572d-e0e1-4d37-b3c4-b85415d50393"], "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": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72865-148-01)", "package_ndc": "72865-148-01", "marketing_start_date": "20210727"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72865-148-05)", "package_ndc": "72865-148-05", "marketing_start_date": "20210727"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (72865-148-10)", "package_ndc": "72865-148-10", "marketing_start_date": "20210727"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72865-148-30)", "package_ndc": "72865-148-30", "marketing_start_date": "20210727"}], "brand_name": "Indomethacin", "product_id": "72865-148_f26f7451-69b2-99d7-e053-2a95a90af7a1", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72865-148", "generic_name": "Indomethacin", "labeler_name": "XLCare Pharmaceuticals 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": "20210727", "listing_expiration_date": "20261231"}