ondansetron

Generic: ondansetron

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler natco pharma usa llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-172
Product ID 69339-172_8bc7e584-a388-43b6-9627-e58b7b79b2d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077851
Listing Expiration 2026-12-31
Marketing Start 2022-10-24

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 69339172
Hyphenated Format 69339-172

Supplemental Identifiers

RxCUI
198052 312086
UPC
0369339171059 0369339172018 0369339171011 0369339171035 0369339172032 0369339172056
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 ANDA077851 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69339-172-01)
  • 30 TABLET in 1 BOTTLE (69339-172-03)
  • 500 TABLET in 1 BOTTLE (69339-172-05)
source: ndc

Packages (3)

69339-172-01 100 TABLET in 1 BOTTLE (69339-172-01) 69339-172-03 30 TABLET in 1 BOTTLE (69339-172-03) 69339-172-05 500 TABLET in 1 BOTTLE (69339-172-05)

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": "8bc7e584-a388-43b6-9627-e58b7b79b2d1", "openfda": {"upc": ["0369339171059", "0369339172018", "0369339171011", "0369339171035", "0369339172032", "0369339172056"], "unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["64527de5-0b92-4340-9243-7a37e8ff96d9"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69339-172-01)", "package_ndc": "69339-172-01", "marketing_start_date": "20250627"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (69339-172-03)", "package_ndc": "69339-172-03", "marketing_start_date": "20221024"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69339-172-05)", "package_ndc": "69339-172-05", "marketing_start_date": "20250627"}], "brand_name": "Ondansetron", "product_id": "69339-172_8bc7e584-a388-43b6-9627-e58b7b79b2d1", "dosage_form": "TABLET", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "69339-172", "generic_name": "Ondansetron", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA077851", "marketing_category": "ANDA", "marketing_start_date": "20221024", "listing_expiration_date": "20261231"}