ondansetron

Generic: ondansetron hydrochloride

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

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-323
Product ID 65219-323_0b0b9b52-bc7d-4c4e-8df5-6c9ab0b268d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076972
Listing Expiration 2026-12-31
Marketing Start 2009-11-18

Pharmacologic Class

Classes
serotonin 3 receptor antagonists [moa] serotonin-3 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219323
Hyphenated Format 65219-323

Supplemental Identifiers

RxCUI
1740467
UPC
0365219323006
UNII
NMH84OZK2B

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 ondansetron (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA076972 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (65219-323-02) / 2 mL in 1 VIAL (65219-323-00)
source: ndc

Packages (1)

65219-323-02 25 VIAL in 1 TRAY (65219-323-02) / 2 mL in 1 VIAL (65219-323-00)

Ingredients (1)

ondansetron hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0b0b9b52-bc7d-4c4e-8df5-6c9ab0b268d5", "openfda": {"upc": ["0365219323006"], "unii": ["NMH84OZK2B"], "rxcui": ["1740467"], "spl_set_id": ["6a231919-6837-4b09-b66d-3706432b9702"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (65219-323-02)  / 2 mL in 1 VIAL (65219-323-00)", "package_ndc": "65219-323-02", "marketing_start_date": "20240122"}], "brand_name": "Ondansetron", "product_id": "65219-323_0b0b9b52-bc7d-4c4e-8df5-6c9ab0b268d5", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "65219-323", "generic_name": "ONDANSETRON HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA076972", "marketing_category": "ANDA", "marketing_start_date": "20091118", "listing_expiration_date": "20261231"}