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 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-857
Product ID 43063-857_3ed995a4-00a5-c1d0-e063-6394a90a0298
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 43063857
Hyphenated Format 43063-857

Supplemental Identifiers

RxCUI
104894
UPC
0343063857052
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
  • 4 mg/1
source: ndc
Packaging
  • 2 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-02)
  • 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-04)
  • 5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-05)
  • 6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-06)
  • 8 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-08)
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-10)
  • 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-20)
source: ndc

Packages (7)

43063-857-02 2 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-02) 43063-857-04 4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-04) 43063-857-05 5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-05) 43063-857-06 6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-06) 43063-857-08 8 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-08) 43063-857-10 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-10) 43063-857-20 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-20)

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": "3ed995a4-00a5-c1d0-e063-6394a90a0298", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0343063857052"], "unii": ["4AF302ESOS"], "rxcui": ["104894"], "spl_set_id": ["9558d296-8edd-4aa1-875a-6247f9a8374d"], "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 (43063-857-02)", "package_ndc": "43063-857-02", "marketing_start_date": "20180604"}, {"sample": false, "description": "4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-04)", "package_ndc": "43063-857-04", "marketing_start_date": "20180612"}, {"sample": false, "description": "5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-05)", "package_ndc": "43063-857-05", "marketing_start_date": "20180612"}, {"sample": false, "description": "6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-06)", "package_ndc": "43063-857-06", "marketing_start_date": "20180604"}, {"sample": false, "description": "8 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-08)", "package_ndc": "43063-857-08", "marketing_start_date": "20180607"}, {"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-10)", "package_ndc": "43063-857-10", "marketing_start_date": "20180618"}, {"sample": false, "description": "20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-857-20)", "package_ndc": "43063-857-20", "marketing_start_date": "20180821"}], "brand_name": "Ondansetron", "product_id": "43063-857_3ed995a4-00a5-c1d0-e063-6394a90a0298", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "43063-857", "generic_name": "Ondansetron", "labeler_name": "PD-Rx Pharmaceuticals, 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"}