indomethacin

Generic: indomethacin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

indomethacin 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-368
Product ID 43063-368_4137a1bb-64c2-e483-e063-6394a90a4f69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091276
Listing Expiration 2026-12-31
Marketing Start 2010-12-22

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 43063368
Hyphenated Format 43063-368

Supplemental Identifiers

RxCUI
197817
UPC
0343063368909
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 ANDA091276 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-06)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-15)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-90)
source: ndc

Packages (4)

43063-368-06 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-06) 43063-368-15 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-15) 43063-368-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-30) 43063-368-90 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-90)

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": "4137a1bb-64c2-e483-e063-6394a90a4f69", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0343063368909"], "unii": ["XXE1CET956"], "rxcui": ["197817"], "spl_set_id": ["b4cf01d1-0d71-4f0f-97a5-07a59744149f"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-06)", "package_ndc": "43063-368-06", "marketing_start_date": "20120223"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-15)", "package_ndc": "43063-368-15", "marketing_start_date": "20170511"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-30)", "package_ndc": "43063-368-30", "marketing_start_date": "20170207"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-90)", "package_ndc": "43063-368-90", "marketing_start_date": "20240606"}], "brand_name": "Indomethacin", "product_id": "43063-368_4137a1bb-64c2-e483-e063-6394a90a4f69", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-368", "generic_name": "Indomethacin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "25 mg/1"}], "application_number": "ANDA091276", "marketing_category": "ANDA", "marketing_start_date": "20101222", "listing_expiration_date": "20261231"}