FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
29300-240
11-digit product format
293000240
Labeler code
29300
Product ID
29300-240_9faf1be0-1f13-47c0-b2aa-3ad62e5037e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA205399
Marketing category
ANDA
Marketing start
2020-08-05
Substance
TOLTERODINE TARTRATE
Active strength
2 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 TARTRATE2 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
29300-240-01Tolterodine Tartrate100 in 1 BOTTLE, PLASTICTABLET1003
29300-240-05Tolterodine Tartrate500 in 1 BOTTLE, PLASTICTABLET5003
29300-240-13Tolterodine Tartrate30 in 1 BOTTLE, PLASTICTABLET303
29300-240-16Tolterodine Tartrate60 in 1 BOTTLE, PLASTICTABLET603
29300-240-19Tolterodine Tartrate90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-240-16EA - Each29300-2409eaa2db1-0d66-4341-bfbf-c0761a28e74012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-240TOLTERODINE TARTRATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]3Current NDC, Legacy NDC, 5 package rows20200808_56e62829-5371-416a-90b3-4b6429532d25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSN56e62829-5371-416a-90b3-4b6429532d253
855194tolterodine tartrate 2 MG Oral TabletPSN56e62829-5371-416a-90b3-4b6429532d253
855178tolterodine tartrate 1 MG Oral TabletSCD56e62829-5371-416a-90b3-4b6429532d253
855194tolterodine tartrate 2 MG Oral TabletSCD56e62829-5371-416a-90b3-4b6429532d253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-240-0129300024001100 TABLET in 1 BOTTLE, PLASTIC (29300-240-01) 100 tablet2020-08-050000-00-00NoNoCurrent
29300-240-0529300024005500 TABLET in 1 BOTTLE, PLASTIC (29300-240-05) 500 tablet2020-08-050000-00-00NoNoCurrent
29300-240-132930002401330 TABLET in 1 BOTTLE, PLASTIC (29300-240-13) 30 tablet2020-08-050000-00-00NoNoCurrent
29300-240-162930002401660 TABLET in 1 BOTTLE, PLASTIC (29300-240-16) 60 tablet2020-08-050000-00-00NoNoCurrent
29300-240-192930002401990 TABLET in 1 BOTTLE, PLASTIC (29300-240-19) 90 tablet2020-08-050000-00-00NoNoCurrent