ondansetron hydrochloride (85509-1075)

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride

Generic Name ondansetron hydrochloride

Labeler phoenix rx llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer

PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1075

Product ID 85509-1075_3f67d4c3-6148-4973-e063-6294a90aa5df

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078539

Listing Expiration 2026-12-31

Marketing Start 2007-07-31

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 855091075

Hyphenated Format 85509-1075

Supplemental Identifiers

RxCUI

198052

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 hydrochloride (source: ndc)

Generic Name ondansetron hydrochloride (source: ndc)

Application Number ANDA078539 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

4 mg/1

source: ndc

Packaging

10 TABLET, FILM COATED in 1 BOTTLE (85509-1075-1)
20 TABLET, FILM COATED in 1 BOTTLE (85509-1075-2)
30 TABLET, FILM COATED in 1 BOTTLE (85509-1075-3)
12 TABLET, FILM COATED in 1 BOTTLE (85509-1075-4)
15 TABLET, FILM COATED in 1 BOTTLE (85509-1075-5)
60 TABLET, FILM COATED in 1 BOTTLE (85509-1075-6)

source: ndc

Packages (6)

85509-1075-1 10 TABLET, FILM COATED in 1 BOTTLE (85509-1075-1) 85509-1075-2 20 TABLET, FILM COATED in 1 BOTTLE (85509-1075-2) 85509-1075-3 30 TABLET, FILM COATED in 1 BOTTLE (85509-1075-3) 85509-1075-4 12 TABLET, FILM COATED in 1 BOTTLE (85509-1075-4) 85509-1075-5 15 TABLET, FILM COATED in 1 BOTTLE (85509-1075-5) 85509-1075-6 60 TABLET, FILM COATED in 1 BOTTLE (85509-1075-6)

Ingredients (1)

ondansetron hydrochloride (4 mg/1)

Linked Drug Pages (1)

Ondansetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3f67d4c3-6148-4973-e063-6294a90aa5df", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052"], "spl_set_id": ["3a79fc2b-9ea3-a808-e063-6394a90ae794"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (85509-1075-1)", "package_ndc": "85509-1075-1", "marketing_start_date": "20250731"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (85509-1075-2)", "package_ndc": "85509-1075-2", "marketing_start_date": "20250731"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (85509-1075-3)", "package_ndc": "85509-1075-3", "marketing_start_date": "20250731"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (85509-1075-4)", "package_ndc": "85509-1075-4", "marketing_start_date": "20250731"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (85509-1075-5)", "package_ndc": "85509-1075-5", "marketing_start_date": "20250731"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (85509-1075-6)", "package_ndc": "85509-1075-6", "marketing_start_date": "20250731"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "85509-1075_3f67d4c3-6148-4973-e063-6294a90aa5df", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "85509-1075", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "PHOENIX RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20070731", "listing_expiration_date": "20261231"}