ondansetron

Generic: ondansetron hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6551
Product ID 0904-6551_50aa5f42-2197-43a5-836a-4e0c96209a8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076183
Listing Expiration 2026-12-31
Marketing Start 2006-12-26

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 09046551
Hyphenated Format 0904-6551

Supplemental Identifiers

RxCUI
198052 312086
UNII
NMH84OZK2B

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 ANDA076183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6551-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6551-61 100 BLISTER PACK in 1 CARTON (0904-6551-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ondansetron hydrochloride (4 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": "50aa5f42-2197-43a5-836a-4e0c96209a8b", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["a29b5c18-9884-4c88-8827-65d9ad5f69f6"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6551-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6551-61", "marketing_start_date": "20061226"}], "brand_name": "ondansetron", "product_id": "0904-6551_50aa5f42-2197-43a5-836a-4e0c96209a8b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "0904-6551", "generic_name": "ondansetron hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076183", "marketing_category": "ANDA", "marketing_start_date": "20061226", "listing_expiration_date": "20261231"}