ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-159
Product ID 16714-159_9e8d8ea3-cbef-49ef-bcda-3ae6b9ea68d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2021-04-06

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 16714159
Hyphenated Format 16714-159

Supplemental Identifiers

RxCUI
198052 312086
UPC
0316714160016 0316714159010
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 ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16714-159-01)
source: ndc

Packages (1)

16714-159-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-159-01)

Ingredients (1)

ondansetron hydrochloride (4 mg/1)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e8d8ea3-cbef-49ef-bcda-3ae6b9ea68d1", "openfda": {"upc": ["0316714160016", "0316714159010"], "unii": ["NMH84OZK2B"], "rxcui": ["198052", "312086"], "spl_set_id": ["9d5e7650-95be-4b96-b29c-374f673eb7a1"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-159-01)", "package_ndc": "16714-159-01", "marketing_start_date": "20210406"}], "brand_name": "Ondansetron", "product_id": "16714-159_9e8d8ea3-cbef-49ef-bcda-3ae6b9ea68d1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "16714-159", "generic_name": "Ondansetron", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20210406", "listing_expiration_date": "20261231"}