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 INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1377
Product ID 51662-1377_12504be9-9bd0-31db-e063-6394a90abc57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076974
Listing Expiration 2026-12-31
Marketing Start 2020-05-21

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 516621377
Hyphenated Format 51662-1377

Supplemental Identifiers

RxCUI
283504
UPC
0363323374204
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 ANDA076974 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 20 mL in 1 VIAL (51662-1377-1)
source: ndc

Packages (1)

51662-1377-1 20 mL in 1 VIAL (51662-1377-1)

Ingredients (1)

ondansetron hydrochloride (2 mg/mL)

Linked Drug Pages (1)

ONDANSETRON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "12504be9-9bd0-31db-e063-6394a90abc57", "openfda": {"upc": ["0363323374204"], "unii": ["NMH84OZK2B"], "rxcui": ["283504"], "spl_set_id": ["a62e2a6a-6235-7580-e053-2a95a90aa2b0"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL (51662-1377-1)", "package_ndc": "51662-1377-1", "marketing_start_date": "20200521"}], "brand_name": "ONDANSETRON", "product_id": "51662-1377_12504be9-9bd0-31db-e063-6394a90abc57", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "51662-1377", "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": "2 mg/mL"}], "application_number": "ANDA076974", "marketing_category": "ANDA", "marketing_start_date": "20200521", "listing_expiration_date": "20261231"}