ondansetron hcl

Generic: ondansetron hcl

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hcl
Generic Name ondansetron hcl
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0074
Product ID 80425-0074_2a98ff70-0365-7169-e063-6394a90adc74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2020-09-16

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 804250074
Hyphenated Format 80425-0074

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 hcl (source: ndc)
Generic Name ondansetron hcl (source: ndc)
Application Number ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (80425-0074-1)
  • 15 TABLET, FILM COATED in 1 BOTTLE (80425-0074-2)
  • 20 TABLET, FILM COATED in 1 BOTTLE (80425-0074-3)
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0074-4)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0074-5)
source: ndc

Packages (5)

80425-0074-1 10 TABLET, FILM COATED in 1 BOTTLE (80425-0074-1) 80425-0074-2 15 TABLET, FILM COATED in 1 BOTTLE (80425-0074-2) 80425-0074-3 20 TABLET, FILM COATED in 1 BOTTLE (80425-0074-3) 80425-0074-4 30 TABLET, FILM COATED in 1 BOTTLE (80425-0074-4) 80425-0074-5 60 TABLET, FILM COATED in 1 BOTTLE (80425-0074-5)

Ingredients (1)

ondansetron hydrochloride (8 mg/1)

Linked Drug Pages (1)

Ondansetron HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a98ff70-0365-7169-e063-6394a90adc74", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["af735f22-6d6c-6e1f-e053-2a95a90a3532"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (80425-0074-1)", "package_ndc": "80425-0074-1", "marketing_start_date": "20200916"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (80425-0074-2)", "package_ndc": "80425-0074-2", "marketing_start_date": "20200916"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (80425-0074-3)", "package_ndc": "80425-0074-3", "marketing_start_date": "20200916"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0074-4)", "package_ndc": "80425-0074-4", "marketing_start_date": "20200916"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0074-5)", "package_ndc": "80425-0074-5", "marketing_start_date": "20200916"}], "brand_name": "Ondansetron HCL", "product_id": "80425-0074_2a98ff70-0365-7169-e063-6394a90adc74", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "80425-0074", "generic_name": "Ondansetron HCL", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron HCL", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20200916", "listing_expiration_date": "20261231"}