Tolvaptan Kit
NDC 0480-3312

Kit
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0480-3312?
  5. Tolvaptan Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

Tolvaptan is a ANDA-approved product labeled by Teva Pharmaceuticals, Inc.. This medication is used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). It is supplied as a kit. This product entry covers the primary NDC 0480-3312 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0480-3312
Proprietary Name:
Tolvaptan
Non-Proprietary Name: [1]
Tolvaptan
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Teva Pharmaceuticals, Inc.
Labeler Code:
0480
Product Label ID:
808a9a1f-2f58-4677-9127-e749ad007094
FDA Application Number: [6]
ANDA216933
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-27-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
Tolvaptan (NDC 0480-4082): WHITE (C48325 - WHITE TO OFF-WHITE)
Tolvaptan (NDC 0480-3265): WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
Tolvaptan (NDC 0480-4082): SQUARE (C48350)
Tolvaptan (NDC 0480-3265): TRIANGLE (C48353)
Size(s):
Tolvaptan (NDC 0480-4082): 8 MM
Tolvaptan (NDC 0480-3265): 6 MM
Imprint(s):
Tolvaptan (NDC 0480-4082): T8
Tolvaptan (NDC 0480-3265): A3
Score:
Tolvaptan (NDC 0480-4082): 1
Tolvaptan (NDC 0480-3265): 1

Code Structure Chart

Product Details

What is NDC 0480-3312?

The NDC code 0480-3312 is assigned by the FDA to the product Tolvaptan. This pharmaceutical product is labeled by Teva Pharmaceuticals, Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0480-3312-66. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This inherited kidney problem leads to the growth of fluid-filled sacs (cysts) in your kidneys. Over time, the cysts grow in size, which can damage the way your kidneys work and lead to kidney failure. Tolvaptan belongs to a class of drugs known as vasopressin receptor antagonists. It works by slowing the growth of kidney cysts caused by ADPKD. This effect helps protect your kidneys from damage and failure. Different brands of this medication have different uses. Do not change brands of this medication unless directed by your doctor.

Which are the associated UNII Codes?

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

  • Tolvaptan (NDC 0480-4082)
  • Tolvaptan (NDC 0480-3265)

Which are the Inactive Ingredients associated 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:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".