ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

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

ondansetron hydrochloride 8 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3801
Product ID 68071-3801_2eeb34c0-0917-f263-e063-6294a90ac1f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2021-04-06

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 680713801
Hyphenated Format 68071-3801

Supplemental Identifiers

RxCUI
312086
UPC
0368071380118
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 (source: ndc)
Generic Name ondansetron (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 (68071-3801-1)
source: ndc

Packages (1)

68071-3801-1 10 TABLET, FILM COATED in 1 BOTTLE (68071-3801-1)

Ingredients (1)

ondansetron hydrochloride (8 mg/1)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2eeb34c0-0917-f263-e063-6294a90ac1f2", "openfda": {"upc": ["0368071380118"], "unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["2eeb3c61-4ce9-d8ed-e063-6294a90a00d3"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (68071-3801-1)", "package_ndc": "68071-3801-1", "marketing_start_date": "20250224"}], "brand_name": "Ondansetron", "product_id": "68071-3801_2eeb34c0-0917-f263-e063-6294a90ac1f2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "68071-3801", "generic_name": "Ondansetron", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20210406", "listing_expiration_date": "20261231"}