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 43063-870
Product ID 43063-870_3edb7f33-6452-d407-e063-6394a90a3977
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 43063870
Hyphenated Format 43063-870

Supplemental Identifiers

RxCUI
312087
UPC
0343063870044
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
  • 2 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-02)
  • 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-04)
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-10)
source: ndc

Packages (3)

43063-870-02 2 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-02) 43063-870-04 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-04) 43063-870-10 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-10)

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": "3edb7f33-6452-d407-e063-6394a90a3977", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0343063870044"], "unii": ["4AF302ESOS"], "rxcui": ["312087"], "spl_set_id": ["10afd68b-877f-4819-a314-39f2d56d5db9"], "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": "2 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-02)", "package_ndc": "43063-870-02", "marketing_start_date": "20190401"}, {"sample": false, "description": "4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-04)", "package_ndc": "43063-870-04", "marketing_start_date": "20180717"}, {"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-870-10)", "package_ndc": "43063-870-10", "marketing_start_date": "20180726"}], "brand_name": "Ondansetron", "product_id": "43063-870_3edb7f33-6452-d407-e063-6394a90a3977", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "43063-870", "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": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20100412", "listing_expiration_date": "20261231"}