Tolterodine tartrate

Product NDC
27241-192
11-digit product format
272410192
Labeler code
27241
Product ID
27241-192_cf018a04-660f-4119-898f-1877a5db8e7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213397
Marketing category
ANDA
Marketing start
2020-06-25
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
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-192-05Tolterodine tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
27241-192-30Tolterodine tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
27241-192-90Tolterodine tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-192-05EA - Each27241-192f220a613-4745-44e8-b1d2-996b4be9883b12020-09-14
27241-192-30EA - Each27241-192639a1837-75b4-407c-b71e-81c44582728d12020-09-14
27241-192-90EA - Each27241-192db3807f9-93bb-441c-b578-56a6d3915d4412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-192TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [AJANTA PHARMA USA INC.]4Current NDC, Legacy NDC, 3 package rows20211126_fcaca033-cd08-4b8c-9bad-7b6751faf2c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNfcaca033-cd08-4b8c-9bad-7b6751faf2c95
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNfcaca033-cd08-4b8c-9bad-7b6751faf2c95
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDfcaca033-cd08-4b8c-9bad-7b6751faf2c95
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDfcaca033-cd08-4b8c-9bad-7b6751faf2c95
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYfcaca033-cd08-4b8c-9bad-7b6751faf2c95
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYfcaca033-cd08-4b8c-9bad-7b6751faf2c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-192-0527241019205500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-05) 2020-06-250000-00-00NoNoCurrent
27241-192-302724101923030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-30) 2020-06-250000-00-00NoNoCurrent
27241-192-902724101929090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-90) 2020-06-250000-00-00NoNoCurrent