ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler asclemed usa, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-251
Product ID 76420-251_2eaaa08a-db13-8991-e063-6294a90ac450
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2026-12-31
Marketing Start 2010-04-12

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420251
Hyphenated Format 76420-251

Supplemental Identifiers

RxCUI
104894 312087
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 ANDA090469 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-04)
  • 6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-06)
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-10)
  • 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-20)
  • 3 BLISTER PACK in 1 CARTON (76420-251-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (5)

76420-251-04 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-04) 76420-251-06 6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-06) 76420-251-10 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-10) 76420-251-20 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-20) 76420-251-30 3 BLISTER PACK in 1 CARTON (76420-251-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

ondansetron (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": "2eaaa08a-db13-8991-e063-6294a90ac450", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["e436e361-da0f-7d6d-e053-2995a90a10e4"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-04)", "package_ndc": "76420-251-04", "marketing_start_date": "20220720"}, {"sample": false, "description": "6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-06)", "package_ndc": "76420-251-06", "marketing_start_date": "20220720"}, {"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-10)", "package_ndc": "76420-251-10", "marketing_start_date": "20220720"}, {"sample": false, "description": "20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-20)", "package_ndc": "76420-251-20", "marketing_start_date": "20220720"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (76420-251-30)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "76420-251-30", "marketing_start_date": "20220720"}], "brand_name": "Ondansetron", "product_id": "76420-251_2eaaa08a-db13-8991-e063-6294a90ac450", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "76420-251", "generic_name": "Ondansetron", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20100412", "listing_expiration_date": "20261231"}