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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-122
Product ID 62135-122_1ba47f65-782d-bcae-e063-6294a90a39a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077406
Listing Expiration 2026-12-31
Marketing Start 2006-12-26

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 62135122
Hyphenated Format 62135-122

Supplemental Identifiers

RxCUI
104894 312087 2685489 2685613
UPC
0362135879303 0362135121303 0362135878306 0362135122300
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 ANDA077406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-122-30)
source: ndc

Packages (1)

62135-122-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-122-30)

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": "1ba47f65-782d-bcae-e063-6294a90a39a5", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0362135879303", "0362135121303", "0362135878306", "0362135122300"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087", "2685489", "2685613"], "spl_set_id": ["4c74336c-11ec-420a-80e1-d8e4a8f1c46d"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-122-30)", "package_ndc": "62135-122-30", "marketing_start_date": "20220330"}], "brand_name": "Ondansetron", "product_id": "62135-122_1ba47f65-782d-bcae-e063-6294a90a39a5", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "62135-122", "generic_name": "Ondansetron", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA077406", "marketing_category": "ANDA", "marketing_start_date": "20061226", "listing_expiration_date": "20261231"}