FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
51407-740
11-digit product format
514070740
Labeler code
51407
Product ID
51407-740_47bbd926-55d2-107f-e063-6294a90a86f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA204562
Marketing category
ANDA
Marketing start
2019-08-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tolterodine Tartrate
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-740-05Tolterodine Tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
51407-740-30Tolterodine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
51407-740-90Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-740-05EA - Each51407-740ce988864-9aff-4061-87be-de9d8168376812023-10-16
51407-740-30EA - Each51407-7408fc715e9-6070-488e-948c-e470210d243b12023-10-16
51407-740-90EA - Each51407-74092fe9128-6798-4f53-820a-0048458115d312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-740TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 3 package rows20231229_05b92da2-923b-3c04-e063-6394a90a69a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN05b92da2-923b-3c04-e063-6394a90a69a15
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN05b92da2-923b-3c04-e063-6394a90a69a15
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD05b92da2-923b-3c04-e063-6394a90a69a15
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD05b92da2-923b-3c04-e063-6394a90a69a15
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY05b92da2-923b-3c04-e063-6394a90a69a15
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY05b92da2-923b-3c04-e063-6394a90a69a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-740-0551407074005500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-740-05) 2023-08-11NoNoHistorical
51407-740-305140707403030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-740-30) 2023-08-11NoNoHistorical
51407-740-905140707409090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-740-90) 2023-08-11NoNoHistorical