ondansetron

Generic: ondansetron

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
ACTAVIS PHARMA, INC.

Identifiers & Regulatory

Product NDC 45963-538
Product ID 45963-538_e1564511-77c6-4a81-a0a9-d66af7bc51ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077851
Marketing Start 2007-07-27
Marketing End 2026-04-30

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 45963538
Hyphenated Format 45963-538

Supplemental Identifiers

RxCUI
198052 312086
UPC
0345963539304
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 (source: ndc)
Application Number ANDA077851 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (45963-538-30)
source: ndc

Packages (1)

45963-538-30 30 TABLET, FILM COATED in 1 BOTTLE (45963-538-30)

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": "e1564511-77c6-4a81-a0a9-d66af7bc51ca", "openfda": {"upc": ["0345963539304"], "unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["90d19fd2-6de4-4e55-9469-53b8957c8326"], "manufacturer_name": ["ACTAVIS PHARMA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (45963-538-30)", "package_ndc": "45963-538-30", "marketing_end_date": "20260430", "marketing_start_date": "20070727"}], "brand_name": "Ondansetron", "product_id": "45963-538_e1564511-77c6-4a81-a0a9-d66af7bc51ca", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "45963-538", "generic_name": "Ondansetron", "labeler_name": "ACTAVIS PHARMA, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA077851", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20070727"}