FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
31722-608
11-digit product format
317220608
Labeler code
31722
Product ID
31722-608_e16012ae-5972-470b-8a22-b0626a029e95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA206419
Marketing category
ANDA
Marketing start
2017-06-02
Substance
TOLTERODINE TARTRATE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tolterodine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T619TQR3R
Rxcui855182, 855189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1Product name820250325
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-608-05Tolterodine Tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
31722-608-30Tolterodine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
31722-608-90Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-608-30EA - Each31722-60831445654-a7c8-409c-a567-7de7391a14da12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-608TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 3 package rows20171218_e16012ae-5972-470b-8a22-b0626a029e95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNe16012ae-5972-470b-8a22-b0626a029e951
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNe16012ae-5972-470b-8a22-b0626a029e951
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDe16012ae-5972-470b-8a22-b0626a029e951
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDe16012ae-5972-470b-8a22-b0626a029e951
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYe16012ae-5972-470b-8a22-b0626a029e951
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYe16012ae-5972-470b-8a22-b0626a029e951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-608-0531722060805500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-608-05) 2017-06-020000-00-00NoNoCurrent
31722-608-303172206083030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-608-30) 2017-06-020000-00-00NoNoCurrent
31722-608-903172206089090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-608-90) 2017-06-020000-00-00NoNoCurrent