ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler st. mary's medical park pharmacy
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-658
Product ID 60760-658_4536d878-2855-7b80-e063-6394a90a07ce
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 60760658
Hyphenated Format 60760-658

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, PLASTIC (60760-658-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-60)
source: ndc

Packages (4)

60760-658-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-10) 60760-658-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-15) 60760-658-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-20) 60760-658-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-60)

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": "4536d878-2855-7b80-e063-6394a90a07ce", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["00b17a8e-9d38-a8d4-e063-6294a90a153e"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-10)", "package_ndc": "60760-658-10", "marketing_start_date": "20230620"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-15)", "package_ndc": "60760-658-15", "marketing_start_date": "20250915"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-20)", "package_ndc": "60760-658-20", "marketing_start_date": "20250623"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-658-60)", "package_ndc": "60760-658-60", "marketing_start_date": "20251030"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "60760-658_4536d878-2855-7b80-e063-6394a90a07ce", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "60760-658", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "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"}