ondansetron

Generic: ondansetron hydrochloride

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

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-208
Product ID 65862-208_a839599f-f788-4039-9e34-b443d1c9849b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078776
Listing Expiration 2026-12-31
Marketing Start 2007-11-28

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 65862208
Hyphenated Format 65862-208

Supplemental Identifiers

RxCUI
312085
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 hydrochloride (source: ndc)
Application Number ANDA078776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (65862-208-04) / 50 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE in 1 CARTON (65862-208-50) / 50 mL in 1 BOTTLE
source: ndc

Packages (2)

65862-208-04 1 BOTTLE, PLASTIC in 1 CARTON (65862-208-04) / 50 mL in 1 BOTTLE, PLASTIC 65862-208-50 1 BOTTLE in 1 CARTON (65862-208-50) / 50 mL in 1 BOTTLE

Ingredients (1)

ondansetron hydrochloride (4 mg/5mL)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a839599f-f788-4039-9e34-b443d1c9849b", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["cf10d256-dd89-4a91-a3ed-81db505a79c2"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65862-208-04)  / 50 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65862-208-04", "marketing_start_date": "20071128"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-208-50)  / 50 mL in 1 BOTTLE", "package_ndc": "65862-208-50", "marketing_start_date": "20071128"}], "brand_name": "Ondansetron", "product_id": "65862-208_a839599f-f788-4039-9e34-b443d1c9849b", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "65862-208", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA078776", "marketing_category": "ANDA", "marketing_start_date": "20071128", "listing_expiration_date": "20261231"}