ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ondansetron hydrochloride 4 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-915
Product ID 76420-915_2cbe06c2-92c4-f72d-e063-6294a90aede8
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 76420915
Hyphenated Format 76420-915

Supplemental Identifiers

RxCUI
198052 312084 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
  • 4 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76420-915-00)
  • 3 TABLET, FILM COATED in 1 BOTTLE (76420-915-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76420-915-05)
  • 10 TABLET, FILM COATED in 1 BOTTLE (76420-915-10)
  • 10 BLISTER PACK in 1 CARTON (76420-915-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-915-30)
  • 1 BLISTER PACK in 1 CARTON (76420-915-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-915-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-915-90)
source: ndc

Packages (9)

76420-915-00 1000 TABLET, FILM COATED in 1 BOTTLE (76420-915-00) 76420-915-03 3 TABLET, FILM COATED in 1 BOTTLE (76420-915-03) 76420-915-05 500 TABLET, FILM COATED in 1 BOTTLE (76420-915-05) 76420-915-10 10 TABLET, FILM COATED in 1 BOTTLE (76420-915-10) 76420-915-11 10 BLISTER PACK in 1 CARTON (76420-915-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 76420-915-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-915-30) 76420-915-33 1 BLISTER PACK in 1 CARTON (76420-915-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK 76420-915-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-915-60) 76420-915-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-915-90)

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": "2cbe06c2-92c4-f72d-e063-6294a90aede8", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052", "312084", "312086"], "spl_set_id": ["65b0b2e2-37fd-4d08-9674-954d62bb531a"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76420-915-00)", "package_ndc": "76420-915-00", "marketing_start_date": "20250128"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (76420-915-03)", "package_ndc": "76420-915-03", "marketing_start_date": "20250128"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76420-915-05)", "package_ndc": "76420-915-05", "marketing_start_date": "20250128"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (76420-915-10)", "package_ndc": "76420-915-10", "marketing_start_date": "20250128"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (76420-915-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "76420-915-11", "marketing_start_date": "20250128"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-915-30)", "package_ndc": "76420-915-30", "marketing_start_date": "20250128"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (76420-915-33)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "76420-915-33", "marketing_start_date": "20250128"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-915-60)", "package_ndc": "76420-915-60", "marketing_start_date": "20250128"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-915-90)", "package_ndc": "76420-915-90", "marketing_start_date": "20250128"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "76420-915_2cbe06c2-92c4-f72d-e063-6294a90aede8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "76420-915", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "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"}