FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
31722-806
11-digit product format
317220806
Labeler code
31722
Product ID
31722-806_c9a8a649-3330-59a0-e053-2995a90ad3c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204397
Marketing category
ANDA
Marketing start
2021-08-02
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
31722-806-01Tolterodine Tartrate10 in 1 CARTONTABLET, FILM COATED101
31722-806-02Tolterodine Tartrate10 in 1 CARTONTABLET, FILM COATED101
31722-806-05Tolterodine Tartrate500 in 1 BOTTLETABLET, FILM COATED5001
31722-806-31Tolterodine Tartrate10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-806-32Tolterodine Tartrate10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-806-60Tolterodine Tartrate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-806-05EA - Each31722-8067896ea6c-b894-4d7f-8236-330348bcc95712022-09-12
31722-806-60EA - Each31722-806d538cc94-09bb-4691-84cc-d9be8a4bec2612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-806TOLTERODINE TARTRATE (TOLTERODINE TARTRATE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 6 package rows20210817_f67fce7c-69d3-42ae-8c1d-2e26fd4d7415.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSNf67fce7c-69d3-42ae-8c1d-2e26fd4d74151
855194tolterodine tartrate 2 MG Oral TabletPSNf67fce7c-69d3-42ae-8c1d-2e26fd4d74151
855178tolterodine tartrate 1 MG Oral TabletSCDf67fce7c-69d3-42ae-8c1d-2e26fd4d74151
855194tolterodine tartrate 2 MG Oral TabletSCDf67fce7c-69d3-42ae-8c1d-2e26fd4d74151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-806-013172208060110 BLISTER PACK in 1 CARTON (31722-806-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-31) 10 blister pack2021-08-020000-00-00NoNoCurrent
31722-806-023172208060210 BLISTER PACK in 1 CARTON (31722-806-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-32) 10 blister pack2021-08-020000-00-00NoNoCurrent
31722-806-0531722080605500 TABLET, FILM COATED in 1 BOTTLE (31722-806-05) 2021-08-020000-00-00NoNoCurrent
31722-806-313172208063110 in 1 BLISTER PACKHistorical
31722-806-323172208063210 in 1 BLISTER PACKHistorical
31722-806-603172208066060 TABLET, FILM COATED in 1 BOTTLE (31722-806-60) 2021-08-020000-00-00NoNoCurrent