ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

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

ondansetron hydrochloride 2 mg/mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-520
Product ID 72572-520_0c34b5a6-e21b-41e7-8e7b-61a9706b67e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077541
Listing Expiration 2026-12-31
Marketing Start 2019-11-18

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 72572520
Hyphenated Format 72572-520

Supplemental Identifiers

RxCUI
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 (72572-520-25) / 2 mL in 1 VIAL (72572-520-01)
source: ndc

Packages (1)

72572-520-25 25 VIAL in 1 CARTON (72572-520-25) / 2 mL in 1 VIAL (72572-520-01)

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": "0c34b5a6-e21b-41e7-8e7b-61a9706b67e0", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["1740467"], "spl_set_id": ["70437694-0341-4f3b-824c-06843403443f"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (72572-520-25)  / 2 mL in 1 VIAL (72572-520-01)", "package_ndc": "72572-520-25", "marketing_start_date": "20191118"}], "brand_name": "Ondansetron", "product_id": "72572-520_0c34b5a6-e21b-41e7-8e7b-61a9706b67e0", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "72572-520", "generic_name": "Ondansetron", "labeler_name": "Civica, 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": "20191118", "listing_expiration_date": "20261231"}