ondansetron

Generic: ondansetron

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler proficient rx lp
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-199
Product ID 63187-199_3ccb1196-6b72-478b-ba07-b05849ae83e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078152
Listing Expiration 2026-12-31
Marketing Start 2007-06-27

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187199
Hyphenated Format 63187-199

Supplemental Identifiers

RxCUI
104894 312087
UPC
0363187256050
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 ANDA078152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-10)
  • 20 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-20)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-30)
source: ndc

Packages (3)

63187-199-10 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-10) 63187-199-20 20 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-20) 63187-199-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-30)

Ingredients (1)

ondansetron (8 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": "3ccb1196-6b72-478b-ba07-b05849ae83e6", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0363187256050"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-10)", "package_ndc": "63187-199-10", "marketing_start_date": "20141001"}, {"sample": false, "description": "20 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-20)", "package_ndc": "63187-199-20", "marketing_start_date": "20251111"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-30)", "package_ndc": "63187-199-30", "marketing_start_date": "20250925"}], "brand_name": "Ondansetron", "product_id": "63187-199_3ccb1196-6b72-478b-ba07-b05849ae83e6", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "63187-199", "generic_name": "Ondansetron", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA078152", "marketing_category": "ANDA", "marketing_start_date": "20070627", "listing_expiration_date": "20261231"}