ondansetron

Generic: ondansetron

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-130
Product ID 84549-130_3d5d25eb-8710-ef8c-e063-6394a90a5e03
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 84549130
Hyphenated Format 84549-130

Supplemental Identifiers

RxCUI
1740467
UNII
NMH84OZK2B

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
  • 2 mL in 1 VIAL, SINGLE-USE (84549-130-05)
source: ndc

Packages (1)

84549-130-05 2 mL in 1 VIAL, SINGLE-USE (84549-130-05)

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": "3d5d25eb-8710-ef8c-e063-6394a90a5e03", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["1740467"], "spl_set_id": ["3d5d25eb-8711-ef8c-e063-6394a90a5e03"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, SINGLE-USE (84549-130-05)", "package_ndc": "84549-130-05", "marketing_start_date": "20250901"}], "brand_name": "ONDANSETRON", "product_id": "84549-130_3d5d25eb-8710-ef8c-e063-6394a90a5e03", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "84549-130", "generic_name": "ONDANSETRON", "labeler_name": "ProPharma Distribution", "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"}