ondansetron

Generic: ondansetron

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler hf acquisition co llc, dba healthfirst
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 4 mg/1

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1246
Product ID 51662-1246_2b3800d9-18fc-7f5d-e063-6294a90a7a3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2026-12-31
Marketing Start 2018-11-19

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 516621246
Hyphenated Format 51662-1246

Supplemental Identifiers

RxCUI
104894
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
  • 4 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BAG (51662-1246-4) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

ondansetron (4 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2b3800d9-18fc-7f5d-e063-6294a90a7a3f", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["104894"], "spl_set_id": ["7b062fa9-e004-23d5-e053-2a91aa0a20cd"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BAG (51662-1246-4)  / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "51662-1246-4", "marketing_start_date": "20181119"}], "brand_name": "ONDANSETRON", "product_id": "51662-1246_2b3800d9-18fc-7f5d-e063-6294a90a7a3f", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "51662-1246", "generic_name": "ONDANSETRON", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON", "strength": "4 mg/1"}], "application_number": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20181119", "listing_expiration_date": "20261231"}