ondansetron

Generic: ondansetron

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-273
Product ID 43063-273_48d4d97e-6683-3407-e063-6294a90a9e72
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 43063273
Hyphenated Format 43063-273

Supplemental Identifiers

RxCUI
312087
UPC
0343063273043
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 ANDA078152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-273-04)
source: ndc

Packages (1)

43063-273-04 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-273-04)

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": "48d4d97e-6683-3407-e063-6294a90a9e72", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0343063273043"], "unii": ["4AF302ESOS"], "rxcui": ["312087"], "spl_set_id": ["d117de5f-64e5-464c-b782-de0f07e66c8e"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-273-04)", "package_ndc": "43063-273-04", "marketing_start_date": "20110127"}], "brand_name": "Ondansetron", "product_id": "43063-273_48d4d97e-6683-3407-e063-6294a90a9e72", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "43063-273", "generic_name": "Ondansetron", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}