ondansetron

Generic: ondansetron hydrochloride

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-4091
Product ID 51672-4091_e10032ef-6d48-44cb-9b7f-9a338f35ca51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077009
Listing Expiration 2026-12-31
Marketing Start 2007-11-30

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 516724091
Hyphenated Format 51672-4091

Supplemental Identifiers

RxCUI
312085
UPC
0351672409135
UNII
NMH84OZK2B

Packaging Origin

Original Packager
true

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 hydrochloride (source: ndc)
Application Number ANDA077009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-4091-3) / 50 mL in 1 BOTTLE
source: ndc

Packages (1)

51672-4091-3 1 BOTTLE in 1 CARTON (51672-4091-3) / 50 mL in 1 BOTTLE

Ingredients (1)

ondansetron hydrochloride (4 mg/5mL)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e10032ef-6d48-44cb-9b7f-9a338f35ca51", "openfda": {"upc": ["0351672409135"], "unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["a95ca4f4-c4de-4822-9a08-209d10bf5136"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-4091-3)  / 50 mL in 1 BOTTLE", "package_ndc": "51672-4091-3", "marketing_start_date": "20071130"}], "brand_name": "Ondansetron", "product_id": "51672-4091_e10032ef-6d48-44cb-9b7f-9a338f35ca51", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "51672-4091", "generic_name": "ondansetron hydrochloride", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA077009", "marketing_category": "ANDA", "marketing_start_date": "20071130", "listing_expiration_date": "20261231"}