ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler bryant ranch prepack
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-4306
Product ID 63629-4306_d33adc9e-77b0-4e55-90ab-0944938ccf1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077557
Listing Expiration 2026-12-31
Marketing Start 2007-08-02

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636294306
Hyphenated Format 63629-4306

Supplemental Identifiers

RxCUI
198052 312087
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 (source: ndc)
Application Number ANDA077557 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-0)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-1)
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-2)
  • 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-3)
  • 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-4)
  • 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-5)
  • 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-6)
  • 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-7)
  • 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-8)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-9)
source: ndc

Packages (10)

63629-4306-0 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-0) 63629-4306-1 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-1) 63629-4306-2 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-2) 63629-4306-3 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-3) 63629-4306-4 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-4) 63629-4306-5 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-5) 63629-4306-6 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-6) 63629-4306-7 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-7) 63629-4306-8 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-8) 63629-4306-9 90 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-9)

Ingredients (1)

ondansetron (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": "d33adc9e-77b0-4e55-90ab-0944938ccf1a", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["198052", "312087"], "spl_set_id": ["384a5cfb-05dd-2b79-73f4-a01a47a9eb3e"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-0)", "package_ndc": "63629-4306-0", "marketing_start_date": "20100820"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-1)", "package_ndc": "63629-4306-1", "marketing_start_date": "20130819"}, {"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-2)", "package_ndc": "63629-4306-2", "marketing_start_date": "20130819"}, {"sample": false, "description": "5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-3)", "package_ndc": "63629-4306-3", "marketing_start_date": "20130819"}, {"sample": false, "description": "4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-4)", "package_ndc": "63629-4306-4", "marketing_start_date": "20100820"}, {"sample": false, "description": "6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-5)", "package_ndc": "63629-4306-5", "marketing_start_date": "20100820"}, {"sample": false, "description": "14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-6)", "package_ndc": "63629-4306-6", "marketing_start_date": "20100820"}, {"sample": false, "description": "60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-7)", "package_ndc": "63629-4306-7", "marketing_start_date": "20100820"}, {"sample": false, "description": "12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-8)", "package_ndc": "63629-4306-8", "marketing_start_date": "20100820"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-9)", "package_ndc": "63629-4306-9", "marketing_start_date": "20100820"}], "brand_name": "ONDANSETRON", "product_id": "63629-4306_d33adc9e-77b0-4e55-90ab-0944938ccf1a", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "63629-4306", "generic_name": "ONDANSETRON", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA077557", "marketing_category": "ANDA", "marketing_start_date": "20070802", "listing_expiration_date": "20261231"}