ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0064
Product ID 0054-0064_64864cbd-055c-436b-80cc-a65e6ac6b02d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076960
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 00540064
Hyphenated Format 0054-0064

Supplemental Identifiers

RxCUI
312085
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 hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA076960 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

0054-0064-47 1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS

Ingredients (1)

ondansetron hydrochloride (4 mg/5mL)

Linked Drug Pages (1)

Ondansetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64864cbd-055c-436b-80cc-a65e6ac6b02d", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["1a0c4dc6-643e-4ee7-92a9-edb98049a5ba"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (0054-0064-47)  / 50 mL in 1 BOTTLE, GLASS", "package_ndc": "0054-0064-47", "marketing_start_date": "20061226"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "0054-0064_64864cbd-055c-436b-80cc-a65e6ac6b02d", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "0054-0064", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA076960", "marketing_category": "ANDA", "marketing_start_date": "20061226", "listing_expiration_date": "20261231"}