ondansetron

Generic: ondansetron hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-3551
Product ID 55154-3551_40b3462a-3eba-414d-a595-63f462199bd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076183
Listing Expiration 2027-12-31
Marketing Start 2025-05-05

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 551543551
Hyphenated Format 55154-3551

Supplemental Identifiers

RxCUI
198052 312086
UPC
0055154355100 0055154787901
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
  • 10 BLISTER PACK in 1 BAG (55154-3551-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-3551-0 10 BLISTER PACK in 1 BAG (55154-3551-0) / 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": "40b3462a-3eba-414d-a595-63f462199bd3", "openfda": {"upc": ["0055154355100", "0055154787901"], "unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["cb02f2d7-31a9-4f12-880e-7ce7d85440d4"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-3551-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-3551-0", "marketing_start_date": "20250505"}], "brand_name": "ondansetron", "product_id": "55154-3551_40b3462a-3eba-414d-a595-63f462199bd3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "55154-3551", "generic_name": "ondansetron hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "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": "20250505", "listing_expiration_date": "20271231"}