Tolterodine Tartrate

Product NDC
70436-161
11-digit product format
704360161
Labeler code
70436
Product ID
70436-161_44e07d95-cc64-cae9-e063-6294a90abc45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA213858
Marketing category
ANDA
Marketing start
2021-04-12
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
70436-161-02Tolterodine Tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50013
70436-161-04Tolterodine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3013
70436-161-06Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-161-02EA - Each70436-1615622e534-1f7b-4541-a302-308476a7ab8212021-05-05
70436-161-04EA - Each70436-1614cfd0c74-7724-4ba9-8131-067a072fc19912021-05-05
70436-161-06EA - Each70436-161966cd8ef-4256-469c-897a-63a8a0488ed912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-161TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 3 package rows20241120_bbbee85a-e5e2-24ec-e053-2995a90acfd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNbbbee85a-e5e2-24ec-e053-2995a90acfd813
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNbbbee85a-e5e2-24ec-e053-2995a90acfd813
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDbbbee85a-e5e2-24ec-e053-2995a90acfd813
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDbbbee85a-e5e2-24ec-e053-2995a90acfd813
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYbbbee85a-e5e2-24ec-e053-2995a90acfd813
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYbbbee85a-e5e2-24ec-e053-2995a90acfd813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-161-0270436016102500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-02) 2021-04-120000-00-00NoNoCurrent
70436-161-047043601610430 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-04) 2021-04-120000-00-00NoNoCurrent
70436-161-067043601610690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-161-06) 2021-04-120000-00-00NoNoCurrent