ondansetron

Generic: ondansetron

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-351
Product ID 62135-351_06fce9d8-ee18-4486-e063-6394a90aeeb4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077303
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 62135351
Hyphenated Format 62135-351

Supplemental Identifiers

RxCUI
198052 312086
UPC
0362135351052 0362135350055 0362135351304 0362135350307
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 (source: ndc)
Application Number ANDA077303 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (62135-351-05)
  • 30 TABLET in 1 BOTTLE (62135-351-30)
source: ndc

Packages (2)

62135-351-05 500 TABLET in 1 BOTTLE (62135-351-05) 62135-351-30 30 TABLET in 1 BOTTLE (62135-351-30)

Ingredients (1)

ondansetron hydrochloride (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": "06fce9d8-ee18-4486-e063-6394a90aeeb4", "openfda": {"upc": ["0362135351052", "0362135350055", "0362135351304", "0362135350307"], "unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["88b7432b-f5a7-40f3-9b0c-e7b125f5103c"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (62135-351-05)", "package_ndc": "62135-351-05", "marketing_start_date": "20220420"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-351-30)", "package_ndc": "62135-351-30", "marketing_start_date": "20220420"}], "brand_name": "ONDANSETRON", "product_id": "62135-351_06fce9d8-ee18-4486-e063-6394a90aeeb4", "dosage_form": "TABLET", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "62135-351", "generic_name": "ONDANSETRON", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA077303", "marketing_category": "ANDA", "marketing_start_date": "20070625", "listing_expiration_date": "20261231"}