indocin

Generic: indomethacin

Labeler: zyla life sciences us inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indocin
Generic Name indomethacin
Labeler zyla life sciences us inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

indomethacin 50 mg/1

Manufacturer
Zyla Life Sciences US Inc.

Identifiers & Regulatory

Product NDC 69344-102
Product ID 69344-102_462a8532-9cea-682f-e063-6394a90a50e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073314
Listing Expiration 2026-12-31
Marketing Start 1992-08-31

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 69344102
Hyphenated Format 69344-102

Supplemental Identifiers

RxCUI
197819 206969
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 indocin (source: ndc)
Generic Name indomethacin (source: ndc)
Application Number ANDA073314 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 SUPPOSITORY in 1 BOX (69344-102-33)
source: ndc

Packages (1)

69344-102-33 30 SUPPOSITORY in 1 BOX (69344-102-33)

Ingredients (1)

indomethacin (50 mg/1)

Linked Drug Pages (1)

INDOCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "462a8532-9cea-682f-e063-6394a90a50e4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "rxcui": ["197819", "206969"], "spl_set_id": ["3b36645c-de5e-4263-ae06-2f6ff6a9add2"], "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": ["Zyla Life Sciences US Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 SUPPOSITORY in 1 BOX (69344-102-33)", "package_ndc": "69344-102-33", "marketing_start_date": "19920831"}], "brand_name": "INDOCIN", "product_id": "69344-102_462a8532-9cea-682f-e063-6394a90a50e4", "dosage_form": "SUPPOSITORY", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69344-102", "generic_name": "Indomethacin", "labeler_name": "Zyla Life Sciences US Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INDOCIN", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "50 mg/1"}], "application_number": "ANDA073314", "marketing_category": "ANDA", "marketing_start_date": "19920831", "listing_expiration_date": "20261231"}