ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8185
Product ID 0615-8185_cb0b89ea-904e-424e-9213-80fc4d073fe3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076183
Listing Expiration 2026-12-31
Marketing Start 2006-12-26

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 06158185
Hyphenated Format 0615-8185

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 ANDA076183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00)
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05)
  • 10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10)
  • 12 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39)
source: ndc

Packages (5)

0615-8185-00 5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00) 0615-8185-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05) 0615-8185-10 10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10) 0615-8185-12 12 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12) 0615-8185-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39)

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": "cb0b89ea-904e-424e-9213-80fc4d073fe3", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052"], "spl_set_id": ["00327696-c496-4c83-a63e-9e29fd6246d4"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00)", "package_ndc": "0615-8185-00", "marketing_start_date": "20240422"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05)", "package_ndc": "0615-8185-05", "marketing_start_date": "20200324"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10)", "package_ndc": "0615-8185-10", "marketing_start_date": "20181107"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12)", "package_ndc": "0615-8185-12", "marketing_start_date": "20240126"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39)", "package_ndc": "0615-8185-39", "marketing_start_date": "20181107"}], "brand_name": "ondansetron hydrochloride", "product_id": "0615-8185_cb0b89ea-904e-424e-9213-80fc4d073fe3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "0615-8185", "generic_name": "ondansetron hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ondansetron hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076183", "marketing_category": "ANDA", "marketing_start_date": "20061226", "listing_expiration_date": "20261231"}