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 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-777
Product ID 43063-777_2fb4a521-16d7-d694-e063-6294a90a954e
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 43063777
Hyphenated Format 43063-777

Supplemental Identifiers

RxCUI
197818
UPC
0343063777206
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 ANDA091240 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-20)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-30)
source: ndc

Packages (2)

43063-777-20 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-20) 43063-777-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-30)

Ingredients (1)

indomethacin (50 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": "2fb4a521-16d7-d694-e063-6294a90a954e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0343063777206"], "unii": ["XXE1CET956"], "rxcui": ["197818"], "spl_set_id": ["d66ada00-3ece-4b71-8c59-a0db48a2db80"], "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": "20 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-20)", "package_ndc": "43063-777-20", "marketing_start_date": "20171103"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-777-30)", "package_ndc": "43063-777-30", "marketing_start_date": "20170801"}], "brand_name": "Indomethacin", "product_id": "43063-777_2fb4a521-16d7-d694-e063-6294a90a954e", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-777", "generic_name": "Indomethacin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "50 mg/1"}], "application_number": "ANDA091240", "marketing_category": "ANDA", "marketing_start_date": "20160519", "listing_expiration_date": "20261231"}