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 50090-4671
Product ID 50090-4671_1f419776-f8b7-40fd-aaea-038d16459e4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2027-12-31
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 500904671
Hyphenated Format 50090-4671

Supplemental Identifiers

RxCUI
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 (50090-4671-0)
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-4671-1)
  • 3 TABLET, FILM COATED in 1 BOTTLE (50090-4671-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-4671-3)
  • 6 TABLET, FILM COATED in 1 BOTTLE (50090-4671-4)
source: ndc

Packages (5)

50090-4671-0 4 TABLET, FILM COATED in 1 BOTTLE (50090-4671-0) 50090-4671-1 10 TABLET, FILM COATED in 1 BOTTLE (50090-4671-1) 50090-4671-2 3 TABLET, FILM COATED in 1 BOTTLE (50090-4671-2) 50090-4671-3 30 TABLET, FILM COATED in 1 BOTTLE (50090-4671-3) 50090-4671-4 6 TABLET, FILM COATED in 1 BOTTLE (50090-4671-4)

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": "1f419776-f8b7-40fd-aaea-038d16459e4d", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["e0f69f57-aeb9-4890-85aa-e5976208e8be"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (50090-4671-0)", "package_ndc": "50090-4671-0", "marketing_start_date": "20191101"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (50090-4671-1)", "package_ndc": "50090-4671-1", "marketing_start_date": "20191101"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (50090-4671-2)", "package_ndc": "50090-4671-2", "marketing_start_date": "20191101"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-4671-3)", "package_ndc": "50090-4671-3", "marketing_start_date": "20191101"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (50090-4671-4)", "package_ndc": "50090-4671-4", "marketing_start_date": "20191101"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "50090-4671_1f419776-f8b7-40fd-aaea-038d16459e4d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "50090-4671", "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": "20271231"}