ondansetron

Generic: ondansetron

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler apotex corp.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6130
Product ID 60505-6130_96665be2-8af7-4ee7-89f4-bdceb16913a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203711
Listing Expiration 2026-12-31
Marketing Start 2016-05-26

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 605056130
Hyphenated Format 60505-6130

Supplemental Identifiers

RxCUI
1740467
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 (source: ndc)
Application Number ANDA203711 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-USE in 1 CARTON (60505-6130-5) / 2 mL in 1 VIAL, SINGLE-USE (60505-6130-0)
source: ndc

Packages (1)

60505-6130-5 25 VIAL, SINGLE-USE in 1 CARTON (60505-6130-5) / 2 mL in 1 VIAL, SINGLE-USE (60505-6130-0)

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": "96665be2-8af7-4ee7-89f4-bdceb16913a7", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["1740467"], "spl_set_id": ["2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-USE in 1 CARTON (60505-6130-5)  / 2 mL in 1 VIAL, SINGLE-USE (60505-6130-0)", "package_ndc": "60505-6130-5", "marketing_start_date": "20160526"}], "brand_name": "ONDANSETRON", "product_id": "60505-6130_96665be2-8af7-4ee7-89f4-bdceb16913a7", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "60505-6130", "generic_name": "ONDANSETRON", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA203711", "marketing_category": "ANDA", "marketing_start_date": "20160526", "listing_expiration_date": "20261231"}