ondansetron

Generic: ondansetron

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-114
Product ID 68083-114_2f33d54b-c852-4bca-ab80-a2852c1be9b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090648
Listing Expiration 2026-12-31
Marketing Start 2012-06-15

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 68083114
Hyphenated Format 68083-114

Supplemental Identifiers

RxCUI
283504
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 (source: ndc)
Application Number ANDA090648 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-114-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

68083-114-01 1 VIAL in 1 CARTON (68083-114-01) / 20 mL in 1 VIAL

Ingredients (1)

ondansetron hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "2f33d54b-c852-4bca-ab80-a2852c1be9b8", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["283504"], "spl_set_id": ["35716914-ac73-43c0-9aa0-09c99211d941"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-114-01)  / 20 mL in 1 VIAL", "package_ndc": "68083-114-01", "marketing_start_date": "20120615"}], "brand_name": "Ondansetron", "product_id": "68083-114_2f33d54b-c852-4bca-ab80-a2852c1be9b8", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "68083-114", "generic_name": "Ondansetron", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA090648", "marketing_category": "ANDA", "marketing_start_date": "20120615", "listing_expiration_date": "20261231"}