ondansetron hydrochloride

Generic: ondansetron hydrochloride

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

Drug Facts

Product Profile

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

ondansetron hydrochloride 8 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-188
Product ID 65862-188_8934ad79-3eda-46d1-b527-53d122760a89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2007-07-31

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 65862188
Hyphenated Format 65862-188

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 ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65862-188-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-188-05)
  • 10 BLISTER PACK in 1 CARTON (65862-188-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-188-30)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-188-99)
source: ndc

Packages (5)

65862-188-03 1 BLISTER PACK in 1 CARTON (65862-188-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 65862-188-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-188-05) 65862-188-10 10 BLISTER PACK in 1 CARTON (65862-188-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-188-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-188-30) 65862-188-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-188-99)

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": "8934ad79-3eda-46d1-b527-53d122760a89", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052", "312084", "312086"], "spl_set_id": ["57578387-1918-4e56-a564-f14fb22340bf"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-188-03)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-188-03", "marketing_start_date": "20070731"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-188-05)", "package_ndc": "65862-188-05", "marketing_start_date": "20070731"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-188-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-188-10", "marketing_start_date": "20070731"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-188-30)", "package_ndc": "65862-188-30", "marketing_start_date": "20070731"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-188-99)", "package_ndc": "65862-188-99", "marketing_start_date": "20070731"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "65862-188_8934ad79-3eda-46d1-b527-53d122760a89", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "65862-188", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20070731", "listing_expiration_date": "20261231"}