ondansetron

Generic: ondansetron

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler northwind health company, llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-196
Product ID 51655-196_499ec3dc-f95c-656c-e063-6294a90a145b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2027-12-31
Marketing Start 2022-07-20

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 51655196
Hyphenated Format 51655-196

Supplemental Identifiers

RxCUI
312087
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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
  • 8 mg/1
source: ndc
Packaging
  • 4 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-04)
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-53)
  • 8 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-80)
  • 6 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-87)
source: ndc

Packages (4)

51655-196-04 4 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-04) 51655-196-53 10 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-53) 51655-196-80 8 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-80) 51655-196-87 6 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-87)

Ingredients (1)

ondansetron (8 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": "499ec3dc-f95c-656c-e063-6294a90a145b", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["312087"], "spl_set_id": ["f2b502e2-03ed-fe5c-e053-2995a90a368e"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-04)", "package_ndc": "51655-196-04", "marketing_start_date": "20230427"}, {"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-53)", "package_ndc": "51655-196-53", "marketing_start_date": "20220720"}, {"sample": false, "description": "8 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-80)", "package_ndc": "51655-196-80", "marketing_start_date": "20220720"}, {"sample": false, "description": "6 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-87)", "package_ndc": "51655-196-87", "marketing_start_date": "20230313"}], "brand_name": "Ondansetron", "product_id": "51655-196_499ec3dc-f95c-656c-e063-6294a90a145b", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "51655-196", "generic_name": "Ondansetron", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20220720", "listing_expiration_date": "20271231"}