ondansetron

Generic: ondansetron

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler bluepoint laboratories
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-247
Product ID 68001-247_4c462efc-fa5d-642d-e063-6294a90a5b72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078152
Listing Expiration 2027-12-31
Marketing Start 2014-03-13

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 68001247
Hyphenated Format 68001-247

Supplemental Identifiers

RxCUI
104894 312087
UPC
0368001246170 0368001247177 0368001247047 0368001246040
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 ANDA078152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68001-247-04)
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68001-247-16)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68001-247-17)
source: ndc

Packages (3)

68001-247-04 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68001-247-04) 68001-247-16 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68001-247-16) 68001-247-17 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68001-247-17)

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": "4c462efc-fa5d-642d-e063-6294a90a5b72", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0368001246170", "0368001247177", "0368001247047", "0368001246040"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["ed1132ec-c2cd-4646-b69d-26663bb937a4"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68001-247-04)", "package_ndc": "68001-247-04", "marketing_start_date": "20180213"}, {"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68001-247-16)", "package_ndc": "68001-247-16", "marketing_start_date": "20140313"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68001-247-17)", "package_ndc": "68001-247-17", "marketing_start_date": "20140313"}], "brand_name": "Ondansetron", "product_id": "68001-247_4c462efc-fa5d-642d-e063-6294a90a5b72", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "68001-247", "generic_name": "Ondansetron", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA078152", "marketing_category": "ANDA", "marketing_start_date": "20140313", "listing_expiration_date": "20271231"}