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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 4 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-200
Product ID 16714-200_952aa289-4c91-49b8-aad8-610855b0a6e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2026-12-31
Marketing Start 2021-04-27

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714200
Hyphenated Format 16714-200

Supplemental Identifiers

RxCUI
104894 312087
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 ANDA090469 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (16714-200-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10)
source: ndc

Packages (1)

16714-200-30 3 BLISTER PACK in 1 CARTON (16714-200-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10)

Ingredients (1)

ondansetron (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": "952aa289-4c91-49b8-aad8-610855b0a6e1", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["281e4296-1d0e-4602-9912-2685ba1640f6"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (16714-200-30)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10)", "package_ndc": "16714-200-30", "marketing_start_date": "20210427"}], "brand_name": "Ondansetron", "product_id": "16714-200_952aa289-4c91-49b8-aad8-610855b0a6e1", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "16714-200", "generic_name": "Ondansetron", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "4 mg/1"}], "application_number": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20210427", "listing_expiration_date": "20261231"}