FDA.reportPublic FDA data

Tolterodine tartrate

Product NDC
29300-307
11-digit product format
293000307
Labeler code
29300
Product ID
29300-307_1d40a6e0-df38-4fd8-bfea-5d19c9d071ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA216917
Marketing category
ANDA
Marketing start
2024-10-01
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
29300-307-05Tolterodine tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5004
29300-307-13Tolterodine tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
29300-307-19Tolterodine tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-307-13EA - Each29300-307a9cc996d-839f-4195-b2eb-befc655f9fe212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-307TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]4Current NDC, 3 package rows20241001_9710ad7b-93c2-4ec1-95ff-597563be4314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN9710ad7b-93c2-4ec1-95ff-597563be43144
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN9710ad7b-93c2-4ec1-95ff-597563be43144
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD9710ad7b-93c2-4ec1-95ff-597563be43144
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD9710ad7b-93c2-4ec1-95ff-597563be43144
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY9710ad7b-93c2-4ec1-95ff-597563be43144
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY9710ad7b-93c2-4ec1-95ff-597563be43144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
29300-307-0529300030705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-307-05) 2024-10-01NoNoCurrent
29300-307-132930003071330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-307-13) 2024-10-01NoNoCurrent
29300-307-192930003071990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-307-19) 2024-10-01NoNoCurrent