ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler baxter healthcare corporation
Dosage Form SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 36000-012
Product ID 36000-012_f917f6a4-bb84-46ed-ba13-68e4c01097e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078287
Listing Expiration 2026-12-31
Marketing Start 2013-03-13

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 36000012
Hyphenated Format 36000-012

Supplemental Identifiers

RxCUI
283504 1740467
UPC
0336000012256
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 ANDA078287 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (36000-012-25) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

36000-012-25 25 VIAL, SINGLE-DOSE in 1 CARTON (36000-012-25) / 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": "f917f6a4-bb84-46ed-ba13-68e4c01097e6", "openfda": {"upc": ["0336000012256"], "unii": ["NMH84OZK2B"], "rxcui": ["283504", "1740467"], "spl_set_id": ["729d865f-d84a-495e-9456-4bceebb6e03f"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (36000-012-25)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "36000-012-25", "marketing_start_date": "20130313"}], "brand_name": "ONDANSETRON HYDROCHLORIDE", "product_id": "36000-012_f917f6a4-bb84-46ed-ba13-68e4c01097e6", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "36000-012", "generic_name": "ONDANSETRON HYDROCHLORIDE", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON HYDROCHLORIDE", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA078287", "marketing_category": "ANDA", "marketing_start_date": "20130313", "listing_expiration_date": "20261231"}