ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler aurobindo pharma limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-391
Product ID 65862-391_aab5d8ee-a492-4deb-b240-62b1b0eb0aa8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2026-12-31
Marketing Start 2010-04-12

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 65862391
Hyphenated Format 65862-391

Supplemental Identifiers

RxCUI
104894 312087
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 ANDA090469 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65862-391-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-02)
  • 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-05)
  • 3 BLISTER PACK in 1 CARTON (65862-391-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-30)
  • 6000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-66)
source: ndc

Packages (6)

65862-391-01 1 BLISTER PACK in 1 CARTON (65862-391-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 65862-391-02 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-02) 65862-391-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-05) 65862-391-10 3 BLISTER PACK in 1 CARTON (65862-391-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 65862-391-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-30) 65862-391-66 6000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-66)

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": "aab5d8ee-a492-4deb-b240-62b1b0eb0aa8", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["cab63f24-8728-4927-aba5-53e8d2e44cdb"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-391-01)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "65862-391-01", "marketing_start_date": "20210324"}, {"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-02)", "package_ndc": "65862-391-02", "marketing_start_date": "20240412"}, {"sample": false, "description": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-05)", "package_ndc": "65862-391-05", "marketing_start_date": "20240412"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-391-10)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "65862-391-10", "marketing_start_date": "20100412"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-30)", "package_ndc": "65862-391-30", "marketing_start_date": "20100412"}, {"sample": false, "description": "6000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-391-66)", "package_ndc": "65862-391-66", "marketing_start_date": "20100412"}], "brand_name": "Ondansetron", "product_id": "65862-391_aab5d8ee-a492-4deb-b240-62b1b0eb0aa8", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "65862-391", "generic_name": "Ondansetron", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20100412", "listing_expiration_date": "20261231"}