ondansetron

Generic: ondansetron hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 4 mg/2mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 76045-216
Product ID 76045-216_b71a45e3-2b90-4199-b88b-fef27cb394fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202253
Listing Expiration 2026-12-31
Marketing Start 2022-05-31

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 76045216
Hyphenated Format 76045-216

Supplemental Identifiers

RxCUI
1314133
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 hydrochloride (source: ndc)
Application Number ANDA202253 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/2mL
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (76045-216-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00) / 2 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76045-216-20 24 BLISTER PACK in 1 CARTON (76045-216-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00) / 2 mL in 1 SYRINGE, GLASS

Ingredients (1)

ondansetron hydrochloride (4 mg/2mL)

Linked Drug Pages (1)

ONDANSETRON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "b71a45e3-2b90-4199-b88b-fef27cb394fc", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["1314133"], "spl_set_id": ["d89017aa-b8c3-4fd2-8e68-44e2cfd6f290"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (76045-216-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00)  / 2 mL in 1 SYRINGE, GLASS", "package_ndc": "76045-216-20", "marketing_start_date": "20220531"}], "brand_name": "ONDANSETRON", "product_id": "76045-216_b71a45e3-2b90-4199-b88b-fef27cb394fc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "76045-216", "generic_name": "ONDANSETRON HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/2mL"}], "application_number": "ANDA202253", "marketing_category": "ANDA", "marketing_start_date": "20220531", "listing_expiration_date": "20261231"}