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, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1539
Product ID 51662-1539_10351b9f-fb7b-f774-e063-6294a90ad09c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076183
Listing Expiration 2026-12-31
Marketing Start 2021-10-06

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 516621539
Hyphenated Format 51662-1539

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 (source: ndc)
Generic Name ondansetron (source: ndc)
Application Number ANDA076183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 BAG (51662-1539-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

51662-1539-1 4 BLISTER PACK in 1 BAG (51662-1539-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ondansetron hydrochloride (4 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": "10351b9f-fb7b-f774-e063-6294a90ad09c", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052"], "spl_set_id": ["cdb2c4b4-a20a-3f8f-e053-2a95a90aaf72"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 BAG (51662-1539-1)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51662-1539-1", "marketing_start_date": "20211006"}], "brand_name": "ONDANSETRON", "product_id": "51662-1539_10351b9f-fb7b-f774-e063-6294a90ad09c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "51662-1539", "generic_name": "ONDANSETRON", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076183", "marketing_category": "ANDA", "marketing_start_date": "20211006", "listing_expiration_date": "20261231"}