NDC 0009-5191 Detrol La
Tolterodine Tartrate Capsule, Extended Release Oral

Product Information

NDC Product Code0009-5191
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Detrol La
Non-Proprietary Name 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.
Tolterodine Tartrate
Substance Name 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.
Tolterodine Tartrate
Product Type 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.
Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormCapsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Pharmacia And Upjohn Company Llc
Labeler Code0009
SPL SET ID:c98eb213-9c80-4698-9710-a9855059b8bb
FDA Application Number 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.
NDA021228
Marketing Category 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.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-22-2000
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

Product Characteristics

Color(s)BLUE (C48333 - BLUE-GREEN)
BLUE (C48333)
ShapeCAPSULE (C48336)
Size(s)14 MM
16 MM
Imprint(s)2
4
Score1

Product Packages

NDC Code 0009-5191-01

Package Description: 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $11.74705 per EA

NDC Code 0009-5191-02

Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $11.74705 per EA

NDC Code 0009-5191-03

Package Description: 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $11.74705 per EA

Product Details

What is NDC 0009-5191?

The NDC code 0009-5191 is assigned by the FDA to the product Detrol La which is a human prescription drug product labeled by Pharmacia And Upjohn Company Llc. The generic name of Detrol La is tolterodine tartrate. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0009-5191-01 30 capsule, extended release in 1 bottle , 0009-5191-02 90 capsule, extended release in 1 bottle , 0009-5191-03 500 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 Detrol La?

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.

What are Detrol La 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.
  • TOLTERODINE TARTRATE 4 mg/1 - An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.

Which are Detrol La UNII Codes?

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

Which are Detrol La 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:

What is the NDC to RxNorm Crosswalk for Detrol La?

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: 855184 - Detrol LA 2 MG 24HR Extended Release Oral Capsule
  • RxCUI: 855184 - 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule [Detrol]

Which are the Pharmacologic Classes for Detrol La?

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.

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Patient Education

Tolterodine


Tolterodine is used treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Tolterodine is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles preventing bladder contraction.
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Product Label

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