indomethacin

Generic: indomethacin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name indomethacin
Generic Name indomethacin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

indomethacin 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-659
Product ID 63323-659_4ada9870-cf14-4c61-892f-6ad9349c31de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022536
Listing Expiration 2026-12-31
Marketing Start 2010-03-19

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 63323659
Hyphenated Format 63323-659

Supplemental Identifiers

RxCUI
346508
UPC
0363323659943
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 NDA022536 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63323-659-94) / 1 mL in 1 VIAL
source: ndc

Packages (1)

63323-659-94 1 VIAL in 1 CARTON (63323-659-94) / 1 mL in 1 VIAL

Ingredients (1)

indomethacin (1 mg/mL)

Linked Drug Pages (3)

Indomethacin ndc-match (0.9) Indomethacin ndc-match (0.9) Indomethacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4ada9870-cf14-4c61-892f-6ad9349c31de", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0363323659943"], "unii": ["XXE1CET956"], "rxcui": ["346508"], "spl_set_id": ["dd5caa3f-3c09-4034-bf43-2df80c61c07b"], "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": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63323-659-94)  / 1 mL in 1 VIAL", "package_ndc": "63323-659-94", "marketing_start_date": "20100319"}], "brand_name": "Indomethacin", "product_id": "63323-659_4ada9870-cf14-4c61-892f-6ad9349c31de", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63323-659", "generic_name": "INDOMETHACIN", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indomethacin", "active_ingredients": [{"name": "INDOMETHACIN", "strength": "1 mg/mL"}], "application_number": "NDA022536", "marketing_category": "NDA", "marketing_start_date": "20100319", "listing_expiration_date": "20261231"}