ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3185
Product ID 50090-3185_f74fee7b-ae98-4fbb-84fb-23cd573e3936
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2007-07-31

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 500903185
Hyphenated Format 50090-3185

Supplemental Identifiers

RxCUI
198052 312086
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 ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 4 TABLET, FILM COATED in 1 BOTTLE (50090-3185-0)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-1)
  • 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-3)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-4)
source: ndc

Packages (5)

50090-3185-0 4 TABLET, FILM COATED in 1 BOTTLE (50090-3185-0) 50090-3185-1 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-1) 50090-3185-2 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-2) 50090-3185-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-3) 50090-3185-4 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-4)

Ingredients (1)

ondansetron hydrochloride (8 mg/1)

Linked Drug Pages (1)

Ondansetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f74fee7b-ae98-4fbb-84fb-23cd573e3936", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["674ea285-8f84-4603-9655-82200c523fe5"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (50090-3185-0)", "package_ndc": "50090-3185-0", "marketing_start_date": "20180117"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-1)", "package_ndc": "50090-3185-1", "marketing_start_date": "20141128"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-2)", "package_ndc": "50090-3185-2", "marketing_start_date": "20141128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-3)", "package_ndc": "50090-3185-3", "marketing_start_date": "20141128"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-4)", "package_ndc": "50090-3185-4", "marketing_start_date": "20141128"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "50090-3185_f74fee7b-ae98-4fbb-84fb-23cd573e3936", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "50090-3185", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20070731", "listing_expiration_date": "20261231"}