ondansetron

Generic: ondansetron hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-125
Product ID 55150-125_344b6a95-a41f-4ef0-8434-623257a5f9c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202600
Listing Expiration 2026-12-31
Marketing Start 2012-12-21

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 55150125
Hyphenated Format 55150-125

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 hydrochloride (source: ndc)
Application Number ANDA202600 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-125-02) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-125-02 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-125-02) / 2 mL in 1 VIAL, SINGLE-DOSE

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": "344b6a95-a41f-4ef0-8434-623257a5f9c5", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["283504", "1740467"], "spl_set_id": ["1cc94c7a-617c-4238-8248-e3fabc9612c7"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-125-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-125-02", "marketing_start_date": "20121221"}], "brand_name": "Ondansetron", "product_id": "55150-125_344b6a95-a41f-4ef0-8434-623257a5f9c5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "55150-125", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA202600", "marketing_category": "ANDA", "marketing_start_date": "20121221", "listing_expiration_date": "20261231"}