ondansetron

Generic: ondansetron hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-513
Product ID 63187-513_48ce80a1-5af3-465e-96d9-ef192cafafe3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077851
Listing Expiration 2026-12-31
Marketing Start 2007-06-25

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 63187513
Hyphenated Format 63187-513

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 (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA077851 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (63187-513-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE (63187-513-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (63187-513-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-513-30)
source: ndc

Packages (4)

63187-513-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-513-10) 63187-513-15 15 TABLET, FILM COATED in 1 BOTTLE (63187-513-15) 63187-513-20 20 TABLET, FILM COATED in 1 BOTTLE (63187-513-20) 63187-513-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-513-30)

Ingredients (1)

ondansetron hydrochloride (8 mg/1)

Linked Drug Pages (1)

ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48ce80a1-5af3-465e-96d9-ef192cafafe3", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["bde7c22c-0047-4735-8df6-b48e8dfa478a"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63187-513-10)", "package_ndc": "63187-513-10", "marketing_start_date": "20181201"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (63187-513-15)", "package_ndc": "63187-513-15", "marketing_start_date": "20181201"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (63187-513-20)", "package_ndc": "63187-513-20", "marketing_start_date": "20181201"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-513-30)", "package_ndc": "63187-513-30", "marketing_start_date": "20181201"}], "brand_name": "ondansetron", "product_id": "63187-513_48ce80a1-5af3-465e-96d9-ef192cafafe3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "63187-513", "generic_name": "ondansetron hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA077851", "marketing_category": "ANDA", "marketing_start_date": "20070625", "listing_expiration_date": "20261231"}