ondansetron

Generic: ondansetron

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler qilu pharmaceutical co., ltd.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ondansetron hydrochloride 2 mg/mL

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0507
Product ID 67184-0507_cd294344-e9fc-4b11-811f-0a8843db3227
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203711
Listing Expiration 2026-12-31
Marketing Start 2014-09-08

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 671840507
Hyphenated Format 67184-0507

Supplemental Identifiers

RxCUI
1740467
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 ANDA203711 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-USE in 1 CARTON (67184-0507-5) / 2 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

67184-0507-5 5 VIAL, SINGLE-USE in 1 CARTON (67184-0507-5) / 2 mL in 1 VIAL, SINGLE-USE

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": "cd294344-e9fc-4b11-811f-0a8843db3227", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["1740467"], "spl_set_id": ["5e09e262-dadf-4ae0-825e-448ea8dac174"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-USE in 1 CARTON (67184-0507-5)  / 2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "67184-0507-5", "marketing_start_date": "20140908"}], "brand_name": "ONDANSETRON", "product_id": "67184-0507_cd294344-e9fc-4b11-811f-0a8843db3227", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "67184-0507", "generic_name": "ONDANSETRON", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA203711", "marketing_category": "ANDA", "marketing_start_date": "20140908", "listing_expiration_date": "20261231"}