ondansetron

Generic: ondansetron tablets

Labeler: natco pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron tablets
Labeler natco pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
Natco Pharma Limited

Identifiers & Regulatory

Product NDC 63850-0003
Product ID 63850-0003_04819dac-e9c5-4d65-b8e4-15a1fd5a93c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077851
Listing Expiration 2026-12-31
Marketing Start 2007-06-25

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 638500003
Hyphenated Format 63850-0003

Supplemental Identifiers

RxCUI
198052 312086
UPC
0363850000317
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 tablets (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 (63850-0003-1)
source: ndc

Packages (1)

63850-0003-1 30 TABLET, FILM COATED in 1 BOTTLE (63850-0003-1)

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": "04819dac-e9c5-4d65-b8e4-15a1fd5a93c8", "openfda": {"upc": ["0363850000317"], "unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["59c817b7-a1c6-48a5-9bfc-2c381532bfd9"], "manufacturer_name": ["Natco Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63850-0003-1)", "package_ndc": "63850-0003-1", "marketing_start_date": "20070625"}], "brand_name": "Ondansetron", "product_id": "63850-0003_04819dac-e9c5-4d65-b8e4-15a1fd5a93c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "63850-0003", "generic_name": "Ondansetron Tablets", "labeler_name": "Natco Pharma Limited", "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_start_date": "20070625", "listing_expiration_date": "20261231"}