ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: precision dose inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler precision dose inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-763
Product ID 68094-763_058d49ad-8056-4e04-9b29-3e088d9b86d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076960
Listing Expiration 2026-12-31
Marketing Start 2015-02-27

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 68094763
Hyphenated Format 68094-763

Supplemental Identifiers

RxCUI
312085
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 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
  • 3 TRAY in 1 CASE (68094-763-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-763-59)
source: ndc

Packages (1)

68094-763-62 3 TRAY in 1 CASE (68094-763-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-763-59)

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": "058d49ad-8056-4e04-9b29-3e088d9b86d8", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["04800a86-2391-44e6-8763-d65e8a916c26"], "manufacturer_name": ["Precision Dose Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (68094-763-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-763-59)", "package_ndc": "68094-763-62", "marketing_start_date": "20150227"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "68094-763_058d49ad-8056-4e04-9b29-3e088d9b86d8", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "68094-763", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Precision Dose 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": "20150227", "listing_expiration_date": "20261231"}