ondansetron

Generic: ondansetron hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler northstar rx llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-671
Product ID 16714-671_add9275d-a837-48f4-ab0b-01fc50e4545f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078776
Listing Expiration 2026-12-31
Marketing Start 2007-11-28

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 16714671
Hyphenated Format 16714-671

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 (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA078776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (16714-671-02) / 50 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

16714-671-02 1 BOTTLE, PLASTIC in 1 CARTON (16714-671-02) / 50 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ondansetron hydrochloride (4 mg/5mL)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "add9275d-a837-48f4-ab0b-01fc50e4545f", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["ac3dfb81-a4c7-4147-9374-c234153b7c51"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16714-671-02)  / 50 mL in 1 BOTTLE, PLASTIC", "package_ndc": "16714-671-02", "marketing_start_date": "20071128"}], "brand_name": "Ondansetron", "product_id": "16714-671_add9275d-a837-48f4-ab0b-01fc50e4545f", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "16714-671", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA078776", "marketing_category": "ANDA", "marketing_start_date": "20071128", "listing_expiration_date": "20261231"}