ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: onesource specialty pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler onesource specialty pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Onesource Specialty Pharma Limited

Identifiers & Regulatory

Product NDC 83270-160
Product ID 83270-160_438c3d28-8bee-50f0-e063-6394a90a18e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078244
Listing Expiration 2026-12-31
Marketing Start 2023-09-30

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 83270160
Hyphenated Format 83270-160

Supplemental Identifiers

RxCUI
1740467
UPC
0383270160019
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 hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA078244 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (83270-160-03) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83270-160-03 25 VIAL, SINGLE-DOSE in 1 CARTON (83270-160-03) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ondansetron hydrochloride (2 mg/mL)

Linked Drug Pages (1)

ondansetron hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "438c3d28-8bee-50f0-e063-6394a90a18e4", "openfda": {"upc": ["0383270160019"], "unii": ["NMH84OZK2B"], "rxcui": ["1740467"], "spl_set_id": ["438c3d28-8bed-50f0-e063-6394a90a18e4"], "manufacturer_name": ["Onesource Specialty Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (83270-160-03)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83270-160-03", "marketing_start_date": "20230930"}], "brand_name": "ondansetron hydrochloride", "product_id": "83270-160_438c3d28-8bee-50f0-e063-6394a90a18e4", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "83270-160", "generic_name": "ondansetron hydrochloride", "labeler_name": "Onesource Specialty Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ondansetron hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA078244", "marketing_category": "ANDA", "marketing_start_date": "20230930", "listing_expiration_date": "20261231"}