indomethacin

Generic: indomethacin

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

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler zydus pharmaceuticals usa inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

indomethacin 50 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1958
Product ID 70710-1958_472b97d6-5eef-4fc5-8a01-b5466d00715e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216184
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

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 707101958
Hyphenated Format 70710-1958

Supplemental Identifiers

RxCUI
197819
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 ANDA216184 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6)
source: ndc

Packages (1)

70710-1958-7 5 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6)

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": ["RECTAL"], "spl_id": "472b97d6-5eef-4fc5-8a01-b5466d00715e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["197819"], "spl_set_id": ["7c911ac4-db70-44bf-8374-01c8260aa3d4"], "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": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (70710-1958-7)  / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6)", "package_ndc": "70710-1958-7", "marketing_start_date": "20240415"}], "brand_name": "Indomethacin", "product_id": "70710-1958_472b97d6-5eef-4fc5-8a01-b5466d00715e", "dosage_form": "SUPPOSITORY", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70710-1958", "generic_name": "Indomethacin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "50 mg/1"}], "application_number": "ANDA216184", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}