ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8582
Product ID 68788-8582_a1774123-cb6f-4744-9034-657a0cabbeb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2024-02-12

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 687888582
Hyphenated Format 68788-8582

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 (68788-8582-1)
  • 12 TABLET, FILM COATED in 1 BOTTLE (68788-8582-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8582-3)
  • 15 TABLET, FILM COATED in 1 BOTTLE (68788-8582-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8582-6)
source: ndc

Packages (5)

68788-8582-1 10 TABLET, FILM COATED in 1 BOTTLE (68788-8582-1) 68788-8582-2 12 TABLET, FILM COATED in 1 BOTTLE (68788-8582-2) 68788-8582-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8582-3) 68788-8582-5 15 TABLET, FILM COATED in 1 BOTTLE (68788-8582-5) 68788-8582-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8582-6)

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": "a1774123-cb6f-4744-9034-657a0cabbeb3", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["2a30d534-4607-4882-865e-56d2364acaad"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (68788-8582-1)", "package_ndc": "68788-8582-1", "marketing_start_date": "20240212"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (68788-8582-2)", "package_ndc": "68788-8582-2", "marketing_start_date": "20240212"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8582-3)", "package_ndc": "68788-8582-3", "marketing_start_date": "20240212"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (68788-8582-5)", "package_ndc": "68788-8582-5", "marketing_start_date": "20240212"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8582-6)", "package_ndc": "68788-8582-6", "marketing_start_date": "20240212"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "68788-8582_a1774123-cb6f-4744-9034-657a0cabbeb3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "68788-8582", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20240212", "listing_expiration_date": "20261231"}