indocin

Generic: indomethacin

Labeler: zyla life sciences us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name indocin
Generic Name indomethacin
Labeler zyla life sciences us llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

indomethacin 25 mg/5mL

Manufacturer
Zyla Life Sciences US LLC

Identifiers & Regulatory

Product NDC 69344-101
Product ID 69344-101_58959f55-f324-4433-97fc-c3b1b7c199be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018332
Listing Expiration 2026-12-31
Marketing Start 2019-02-04

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 69344101
Hyphenated Format 69344-101

Supplemental Identifiers

RxCUI
206971 310991
UPC
0369344101010
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 NDA018332 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

69344-101-01 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS

Ingredients (1)

indomethacin (25 mg/5mL)

Linked Drug Pages (1)

Indocin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "58959f55-f324-4433-97fc-c3b1b7c199be", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0369344101010"], "unii": ["XXE1CET956"], "rxcui": ["206971", "310991"], "spl_set_id": ["73878376-1d24-423b-9f37-3666e83c95da"], "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 LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (69344-101-01)  / 237 mL in 1 BOTTLE, GLASS", "package_ndc": "69344-101-01", "marketing_start_date": "20190204"}], "brand_name": "Indocin", "product_id": "69344-101_58959f55-f324-4433-97fc-c3b1b7c199be", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69344-101", "generic_name": "indomethacin", "labeler_name": "Zyla Life Sciences US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indocin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "25 mg/5mL"}], "application_number": "NDA018332", "marketing_category": "NDA", "marketing_start_date": "20190204", "listing_expiration_date": "20261231"}