ondansetron

Generic: ondansetron hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0815
Product ID 71335-0815_b638187e-24d5-4c7a-8489-b79e64a2dcfd
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 713350815
Hyphenated Format 71335-0815

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 (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
  • 5 TABLET, FILM COATED in 1 BOTTLE (71335-0815-0)
  • 10 TABLET, FILM COATED in 1 BOTTLE (71335-0815-1)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71335-0815-2)
  • 4 TABLET, FILM COATED in 1 BOTTLE (71335-0815-3)
  • 3 TABLET, FILM COATED in 1 BOTTLE (71335-0815-4)
  • 12 TABLET, FILM COATED in 1 BOTTLE (71335-0815-5)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71335-0815-6)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-0815-7)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0815-8)
  • 6 TABLET, FILM COATED in 1 BOTTLE (71335-0815-9)
source: ndc

Packages (10)

71335-0815-0 5 TABLET, FILM COATED in 1 BOTTLE (71335-0815-0) 71335-0815-1 10 TABLET, FILM COATED in 1 BOTTLE (71335-0815-1) 71335-0815-2 15 TABLET, FILM COATED in 1 BOTTLE (71335-0815-2) 71335-0815-3 4 TABLET, FILM COATED in 1 BOTTLE (71335-0815-3) 71335-0815-4 3 TABLET, FILM COATED in 1 BOTTLE (71335-0815-4) 71335-0815-5 12 TABLET, FILM COATED in 1 BOTTLE (71335-0815-5) 71335-0815-6 20 TABLET, FILM COATED in 1 BOTTLE (71335-0815-6) 71335-0815-7 30 TABLET, FILM COATED in 1 BOTTLE (71335-0815-7) 71335-0815-8 60 TABLET, FILM COATED in 1 BOTTLE (71335-0815-8) 71335-0815-9 6 TABLET, FILM COATED in 1 BOTTLE (71335-0815-9)

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": "b638187e-24d5-4c7a-8489-b79e64a2dcfd", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["37de0550-a6d1-46a8-a0b8-447b0dcf70ad"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE (71335-0815-0)", "package_ndc": "71335-0815-0", "marketing_start_date": "20120824"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (71335-0815-1)", "package_ndc": "71335-0815-1", "marketing_start_date": "20120824"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71335-0815-2)", "package_ndc": "71335-0815-2", "marketing_start_date": "20120824"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (71335-0815-3)", "package_ndc": "71335-0815-3", "marketing_start_date": "20120824"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (71335-0815-4)", "package_ndc": "71335-0815-4", "marketing_start_date": "20120824"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (71335-0815-5)", "package_ndc": "71335-0815-5", "marketing_start_date": "20120824"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71335-0815-6)", "package_ndc": "71335-0815-6", "marketing_start_date": "20120824"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0815-7)", "package_ndc": "71335-0815-7", "marketing_start_date": "20120824"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0815-8)", "package_ndc": "71335-0815-8", "marketing_start_date": "20120824"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (71335-0815-9)", "package_ndc": "71335-0815-9", "marketing_start_date": "20120824"}], "brand_name": "ondansetron", "product_id": "71335-0815_b638187e-24d5-4c7a-8489-b79e64a2dcfd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "71335-0815", "generic_name": "ondansetron hydrochloride", "labeler_name": "Bryant Ranch Prepack", "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"}