indomethacin

Generic: indomethacin

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

Drug Facts

Product Profile

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

indomethacin 25 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-542
Product ID 31722-542_349de484-29cd-3e15-e063-6394a90a5aa5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091240
Listing Expiration 2026-12-31
Marketing Start 2016-05-19

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 31722542
Hyphenated Format 31722-542

Supplemental Identifiers

RxCUI
197817 197818
UPC
0331722543019 0331722542012
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
  • 12 BOTTLE in 1 CASE (31722-542-01) / 100 CAPSULE in 1 BOTTLE
  • 12 BOTTLE in 1 CASE (31722-542-05) / 500 CAPSULE in 1 BOTTLE
  • 12 BOTTLE in 1 CASE (31722-542-10) / 1000 CAPSULE in 1 BOTTLE
  • 12 BOTTLE in 1 CASE (31722-542-30) / 30 CAPSULE in 1 BOTTLE
source: ndc

Packages (4)

31722-542-01 12 BOTTLE in 1 CASE (31722-542-01) / 100 CAPSULE in 1 BOTTLE 31722-542-05 12 BOTTLE in 1 CASE (31722-542-05) / 500 CAPSULE in 1 BOTTLE 31722-542-10 12 BOTTLE in 1 CASE (31722-542-10) / 1000 CAPSULE in 1 BOTTLE 31722-542-30 12 BOTTLE in 1 CASE (31722-542-30) / 30 CAPSULE in 1 BOTTLE

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": "349de484-29cd-3e15-e063-6394a90a5aa5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0331722543019", "0331722542012"], "unii": ["XXE1CET956"], "rxcui": ["197817", "197818"], "spl_set_id": ["1ce9c3c5-0cf7-4760-988d-2559adcfb200"], "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": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BOTTLE in 1 CASE (31722-542-01)  / 100 CAPSULE in 1 BOTTLE", "package_ndc": "31722-542-01", "marketing_start_date": "20160519"}, {"sample": false, "description": "12 BOTTLE in 1 CASE (31722-542-05)  / 500 CAPSULE in 1 BOTTLE", "package_ndc": "31722-542-05", "marketing_start_date": "20160519"}, {"sample": false, "description": "12 BOTTLE in 1 CASE (31722-542-10)  / 1000 CAPSULE in 1 BOTTLE", "package_ndc": "31722-542-10", "marketing_start_date": "20160519"}, {"sample": false, "description": "12 BOTTLE in 1 CASE (31722-542-30)  / 30 CAPSULE in 1 BOTTLE", "package_ndc": "31722-542-30", "marketing_start_date": "20160519"}], "brand_name": "Indomethacin", "product_id": "31722-542_349de484-29cd-3e15-e063-6394a90a5aa5", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "31722-542", "generic_name": "Indomethacin", "labeler_name": "Camber 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": "20160519", "listing_expiration_date": "20261231"}