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  4. NDC Product Code: 68151-2049 Tolterodine Tartrate

NDC 68151-2049 Tolterodine Tartrate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68151-2049?
  5. Tolterodine Tartrate Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
68151-2049
Proprietary Name:
Tolterodine Tartrate
Product Type: [3]
Labeler Name: [5]
Carilion Materials Management
Labeler Code:
68151
Product Label ID:
09b4ec42-9b47-4a6c-b219-7c5dcda35ac5
FDA Application Number: [6]
NDA021228
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date: [9]
01-02-2014
End Marketing Date: [10]
06-17-2016
Listing Expiration Date: [11]
06-17-2016
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
TEVA;2049;TEVA;2049
Score:
1

Code Structure Chart

Product Details

What is NDC 68151-2049?

The NDC code 68151-2049 is assigned by the FDA to the product Tolterodine Tartrate which is product labeled by Carilion Materials Management. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68151-2049-8 1 capsule, extended release in 1 bottle . 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 Tolterodine Tartrate?

This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, tolterodine improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

Which are Tolterodine Tartrate UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Tolterodine Tartrate?

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:
  • RxCUI: 855182 - tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule
  • RxCUI: 855182 - 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule
  • RxCUI: 855182 - tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 855189 - tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule
  • RxCUI: 855189 - 24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule

* Please review the disclaimer below.

Product Footnotes

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".