ondansetron hydrochloride

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 hydrochloride
Generic Name ondansetron hydrochloride
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

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

Identifiers & Regulatory

Product NDC 51672-4109
Product ID 51672-4109_288442cd-0f6b-49e1-9acc-d8f613f54810
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077729
Listing Expiration 2026-12-31
Marketing Start 2011-03-28

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 516724109
Hyphenated Format 51672-4109

Supplemental Identifiers

RxCUI
198052 312084 312086
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 hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA077729 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (51672-4109-0) / 100 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (51672-4109-6)
  • 1 BLISTER PACK in 1 CARTON (51672-4109-8) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

51672-4109-0 1 BLISTER PACK in 1 CARTON (51672-4109-0) / 100 TABLET, FILM COATED in 1 BLISTER PACK 51672-4109-6 30 TABLET, FILM COATED in 1 BOTTLE (51672-4109-6) 51672-4109-8 1 BLISTER PACK in 1 CARTON (51672-4109-8) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ondansetron hydrochloride (8 mg/1)

Linked Drug Pages (1)

Ondansetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "288442cd-0f6b-49e1-9acc-d8f613f54810", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052", "312084", "312086"], "spl_set_id": ["29cda698-cfd4-43e1-b69e-884d08d8918a"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51672-4109-0)  / 100 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51672-4109-0", "marketing_start_date": "20110328"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (51672-4109-6)", "package_ndc": "51672-4109-6", "marketing_start_date": "20110328"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51672-4109-8)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51672-4109-8", "marketing_start_date": "20110328"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "51672-4109_288442cd-0f6b-49e1-9acc-d8f613f54810", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "51672-4109", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA077729", "marketing_category": "ANDA", "marketing_start_date": "20110328", "listing_expiration_date": "20261231"}