ondansetron

Generic: ondansetron

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler accord healthcare, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron 2 mg/mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-298
Product ID 16729-298_424e0911-305e-8eb5-e063-6294a90aaab3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206846
Listing Expiration 2026-12-31
Marketing Start 2016-10-20

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729298
Hyphenated Format 16729-298

Supplemental Identifiers

RxCUI
283504
UPC
0316729298056
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 ANDA206846 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 20 mL in 1 VIAL (16729-298-05)
source: ndc

Packages (1)

16729-298-05 20 mL in 1 VIAL (16729-298-05)

Ingredients (1)

ondansetron (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": "424e0911-305e-8eb5-e063-6294a90aaab3", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0316729298056"], "unii": ["4AF302ESOS"], "rxcui": ["283504"], "spl_set_id": ["35e0d160-813f-41d7-a382-d2cab6485d9c"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL (16729-298-05)", "package_ndc": "16729-298-05", "marketing_start_date": "20161020"}], "brand_name": "ondansetron", "product_id": "16729-298_424e0911-305e-8eb5-e063-6294a90aaab3", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "16729-298", "generic_name": "ondansetron", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "2 mg/mL"}], "application_number": "ANDA206846", "marketing_category": "ANDA", "marketing_start_date": "20161020", "listing_expiration_date": "20261231"}