ondansetron

Generic: ondansetron

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler rising pharma holdings, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 4 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-077
Product ID 57237-077_49380e9c-090e-44fd-b2c9-992e25e26753
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2026-12-31
Marketing Start 2010-04-12

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 57237077
Hyphenated Format 57237-077

Supplemental Identifiers

RxCUI
104894 312087
UPC
0357237078105 0357237077306 0357237078303 0357237077108
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
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-01)
  • 3 BLISTER PACK in 1 CARTON (57237-077-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-30)
  • 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-50)
source: ndc

Packages (4)

57237-077-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-01) 57237-077-10 3 BLISTER PACK in 1 CARTON (57237-077-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 57237-077-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-30) 57237-077-50 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-50)

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": "49380e9c-090e-44fd-b2c9-992e25e26753", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0357237078105", "0357237077306", "0357237078303", "0357237077108"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["eb74425c-c635-4d99-8e98-e63e7359fb89"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-01)", "package_ndc": "57237-077-01", "marketing_start_date": "20240930"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (57237-077-10)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "57237-077-10", "marketing_start_date": "20100412"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-30)", "package_ndc": "57237-077-30", "marketing_start_date": "20100412"}, {"sample": false, "description": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-50)", "package_ndc": "57237-077-50", "marketing_start_date": "20240930"}], "brand_name": "Ondansetron", "product_id": "57237-077_49380e9c-090e-44fd-b2c9-992e25e26753", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "57237-077", "generic_name": "Ondansetron", "labeler_name": "Rising Pharma Holdings, Inc.", "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": "20100412", "listing_expiration_date": "20261231"}