ondansetron

Generic: ondansetron

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-158
Product ID 68462-158_32177a6a-8c35-4e1c-b7f5-7376b1c1316a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078152
Listing Expiration 2027-12-31
Marketing Start 2007-06-27

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 68462158
Hyphenated Format 68462-158

Supplemental Identifiers

RxCUI
104894 198052 312086 312087
UPC
0368462157138 0368462106303 0368462105306 0368462158111
UNII
4AF302ESOS NMH84OZK2B
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
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-11)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-13)
source: ndc

Packages (2)

68462-158-11 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-11) 68462-158-13 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-13)

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": "32177a6a-8c35-4e1c-b7f5-7376b1c1316a", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0368462157138", "0368462106303", "0368462105306", "0368462158111"], "unii": ["4AF302ESOS", "NMH84OZK2B"], "rxcui": ["104894", "198052", "312086", "312087"], "spl_set_id": ["eee5217a-eba8-463a-812d-bf3c66f0934f"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-11)", "package_ndc": "68462-158-11", "marketing_start_date": "20070627"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-13)", "package_ndc": "68462-158-13", "marketing_start_date": "20070627"}], "brand_name": "Ondansetron", "product_id": "68462-158_32177a6a-8c35-4e1c-b7f5-7376b1c1316a", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "68462-158", "generic_name": "Ondansetron", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "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": "20070627", "listing_expiration_date": "20271231"}