ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler cardinal health 107, llc
Dosage Form SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4453
Product ID 55154-4453_f61b876e-8d99-407b-89c0-118fa77c8987
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078287
Listing Expiration 2027-12-31
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 551544453
Hyphenated Format 55154-4453

Supplemental Identifiers

RxCUI
1740467
UPC
0055154445351
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 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
  • 5 VIAL in 1 BAG (55154-4453-5) / 2 mL in 1 VIAL
source: ndc

Packages (1)

55154-4453-5 5 VIAL in 1 BAG (55154-4453-5) / 2 mL in 1 VIAL

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": "f61b876e-8d99-407b-89c0-118fa77c8987", "openfda": {"upc": ["0055154445351"], "unii": ["NMH84OZK2B"], "rxcui": ["1740467"], "spl_set_id": ["30107d6f-5128-484f-b713-65244a98dc67"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 BAG (55154-4453-5)  / 2 mL in 1 VIAL", "package_ndc": "55154-4453-5", "marketing_start_date": "20130313"}], "brand_name": "ONDANSETRON HYDROCHLORIDE", "product_id": "55154-4453_f61b876e-8d99-407b-89c0-118fa77c8987", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "55154-4453", "generic_name": "ONDANSETRON HYDROCHLORIDE", "labeler_name": "Cardinal Health 107, LLC", "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": "20271231"}