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  4. NDC Product Code: 59651-467 Sunitinib Malate

NDC 59651-467 Sunitinib Malate

Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 59651-467?
  5. Sunitinib Malate Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
59651-467
Proprietary Name:
Sunitinib Malate
Non-Proprietary Name: [1]
Sunitinib Malate
Substance Name: [2]
Sunitinib Malate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Aurobindo Pharma Limited
    Labeler Code:
    59651
    Product Label ID:
    810dfcb2-d35b-4971-887c-2e78e82e9e07
    FDA Application Number: [6]
    ANDA218615
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    03-14-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326 - RED OPAQUE CAP, RED OPAQUE BODY)
    GREEN (C48329 - OLIVE GREEN OPAQUE CAP)
    RED (C48326 - RED OPAQUE BODY)
    GREEN (C48329 - LIGHT GREEN OPAQUE CAP, LIGHT GREEN OPAQUE BODY)
    GREEN (C48329 - OLIVE GREEN OPAQUE CAP, OLIVE GREEN OPAQUE BODY)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    16 MM
    18 MM
    Imprint(s):
    S12;5
    S25
    S37;5
    S50
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 59651-467?

    The NDC code 59651-467 is assigned by the FDA to the product Sunitinib Malate which is a human prescription drug product labeled by Aurobindo Pharma Limited. The product's dosage form is capsule and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 59651-467-28 28 capsule in 1 bottle , 59651-467-29 4 blister pack in 1 carton / 7 capsule in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Sunitinib Malate?

    This medication is used to treat certain types of cancer (kidney, pancreas, and intestinal). It is also used to treat people who are at high risk of the kidney cancer coming back again after having kidney surgery. Sunitinib works by stopping or slowing the growth of cancer tumors. It also works by slowing the growth of new blood vessels within the tumor.

    What are Sunitinib Malate Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • SUNITINIB MALATE 50 mg/1 - An indole and pyrrole derivative that inhibits VEGFR-2 and PDGFR BETA RECEPTOR TYROSINE KINASES. It is used as an antineoplastic agent for the treatment of GASTROINTESTINAL STROMAL TUMORS, and for treatment of advanced or metastatic RENAL CELL CARCINOMA.

    Which are Sunitinib Malate UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Sunitinib Malate Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Sunitinib Malate?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".