ondansetron

Generic: ondansetron

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler quality care products, llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 4 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-026
Product ID 83008-026_96d3ce0e-ecf6-4f8c-a148-89ce08e74c36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078152
Marketing Start 2023-05-12
Marketing End 2026-06-30

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 83008026
Hyphenated Format 83008-026

Supplemental Identifiers

RxCUI
104894
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 ANDA078152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (83008-026-10)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (83008-026-65)
source: ndc

Packages (2)

83008-026-10 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (83008-026-10) 83008-026-65 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (83008-026-65)

Ingredients (1)

ondansetron (4 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": "96d3ce0e-ecf6-4f8c-a148-89ce08e74c36", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["104894"], "spl_set_id": ["318c2f90-d4ad-49e7-b885-cfb132b4cd17"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (83008-026-10)", "package_ndc": "83008-026-10", "marketing_end_date": "20260630", "marketing_start_date": "20230512"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (83008-026-65)", "package_ndc": "83008-026-65", "marketing_end_date": "20260331", "marketing_start_date": "20231003"}], "brand_name": "Ondansetron", "product_id": "83008-026_96d3ce0e-ecf6-4f8c-a148-89ce08e74c36", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "83008-026", "generic_name": "Ondansetron", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "4 mg/1"}], "application_number": "ANDA078152", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20230512"}