ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: phoenix rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 8 mg/1

Manufacturer
PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1076
Product ID 85509-1076_3a76c251-0d7a-e587-e063-6394a90a308c
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 855091076
Hyphenated Format 85509-1076

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 hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (85509-1076-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE (85509-1076-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (85509-1076-3)
  • 15 TABLET, FILM COATED in 1 BOTTLE (85509-1076-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (85509-1076-6)
source: ndc

Packages (5)

85509-1076-1 10 TABLET, FILM COATED in 1 BOTTLE (85509-1076-1) 85509-1076-2 20 TABLET, FILM COATED in 1 BOTTLE (85509-1076-2) 85509-1076-3 30 TABLET, FILM COATED in 1 BOTTLE (85509-1076-3) 85509-1076-5 15 TABLET, FILM COATED in 1 BOTTLE (85509-1076-5) 85509-1076-6 60 TABLET, FILM COATED in 1 BOTTLE (85509-1076-6)

Ingredients (1)

ondansetron hydrochloride (8 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": "3a76c251-0d7a-e587-e063-6394a90a308c", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["3a76bae2-04c2-ee2d-e063-6394a90ad4c8"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (85509-1076-1)", "package_ndc": "85509-1076-1", "marketing_start_date": "20250731"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (85509-1076-2)", "package_ndc": "85509-1076-2", "marketing_start_date": "20250731"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (85509-1076-3)", "package_ndc": "85509-1076-3", "marketing_start_date": "20250731"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (85509-1076-5)", "package_ndc": "85509-1076-5", "marketing_start_date": "20250731"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (85509-1076-6)", "package_ndc": "85509-1076-6", "marketing_start_date": "20250731"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "85509-1076_3a76c251-0d7a-e587-e063-6394a90a308c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "85509-1076", "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": "8 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20070731", "listing_expiration_date": "20261231"}