ondansetron

Generic: ondansetron

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6080
Product ID 0641-6080_65dafe3e-7450-46dd-932f-6fff7e4e58b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077541
Listing Expiration 2026-12-31
Marketing Start 2006-12-26

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 06416080
Hyphenated Format 0641-6080

Supplemental Identifiers

RxCUI
283504 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 ANDA077541 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6080-25) / 2 mL in 1 VIAL (0641-6080-01)
source: ndc

Packages (1)

0641-6080-25 25 VIAL in 1 CARTON (0641-6080-25) / 2 mL in 1 VIAL (0641-6080-01)

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": "65dafe3e-7450-46dd-932f-6fff7e4e58b6", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["283504", "1740467"], "spl_set_id": ["97713356-f42b-4a67-95f6-561afa68c0c2"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6080-25)  / 2 mL in 1 VIAL (0641-6080-01)", "package_ndc": "0641-6080-25", "marketing_start_date": "20061226"}], "brand_name": "Ondansetron", "product_id": "0641-6080_65dafe3e-7450-46dd-932f-6fff7e4e58b6", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "0641-6080", "generic_name": "Ondansetron", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA077541", "marketing_category": "ANDA", "marketing_start_date": "20061226", "listing_expiration_date": "20261231"}