Tolterodine Tartrate

Product NDC
16571-126
11-digit product format
165710126
Labeler code
16571
Product ID
16571-126_d56e7ced-4633-4325-8e3d-166c84c05886
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA204721
Marketing category
ANDA
Marketing start
2020-01-24
Substance
TOLTERODINE TARTRATE
Active strength
1 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 TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T619TQR3R
Rxcui855178, 855194

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
16571-126-01Tolterodine Tartrate100 in 1 BOTTLETABLET, FILM COATED1003
16571-126-06Tolterodine Tartrate60 in 1 BOTTLETABLET, FILM COATED603
16571-126-50Tolterodine Tartrate500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-126TOLTERODINE TARTRATE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 3 package rows20200915_b9ba8ad2-27f6-4f18-bd84-73659047910e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSNb9ba8ad2-27f6-4f18-bd84-73659047910e3
855194tolterodine tartrate 2 MG Oral TabletPSNb9ba8ad2-27f6-4f18-bd84-73659047910e3
855178tolterodine tartrate 1 MG Oral TabletSCDb9ba8ad2-27f6-4f18-bd84-73659047910e3
855194tolterodine tartrate 2 MG Oral TabletSCDb9ba8ad2-27f6-4f18-bd84-73659047910e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-126-0116571012601100 TABLET, FILM COATED in 1 BOTTLE (16571-126-01) 2020-01-240000-00-00NoNoCurrent
16571-126-061657101260660 TABLET, FILM COATED in 1 BOTTLE (16571-126-06) 2020-01-240000-00-00NoNoCurrent
16571-126-5016571012650500 TABLET, FILM COATED in 1 BOTTLE (16571-126-50) 2020-01-240000-00-00NoNoCurrent