Tolterodine Tartrate

Product NDC: 68151-4281
11-digit product format: 681514281
Labeler code: 68151
Product ID: 68151-4281_448e25c6-3351-4d69-a0c4-502a53d266c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Carilion Materials Management
Application: NDA021228
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-01-02
Marketing end: 0000-00-00
Substance: TOLTERODINE TARTRATE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1	Product name	8	20250325
a932c194-3a9e-a7d8-8961-eb5843129c16	Product name	6	20220210

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-4281-8	2020-01-31	C162847	48780-1	9d75b9d0-c475-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use tolterodine tartrate extended-release capsules safely and effectively. See full prescribing information for tolterodine tartrate extended-release capsules. Tolterodine tartrate extended-release capsules For oral administration Initial U.S. Approval: December 2000

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-4281-8	Tolterodine Tartrate	1 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-4281	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20160618_ca4b3a0e-0f80-44e7-8cad-587610c6f198.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5T619TQR3R	TOLTERODINE TARTRATE	124937-52-6	TOLTERODINE TARTRATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	ca4b3a0e-0f80-44e7-8cad-587610c6f198	2
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	ca4b3a0e-0f80-44e7-8cad-587610c6f198	2
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	ca4b3a0e-0f80-44e7-8cad-587610c6f198	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-4281-8	68151428108	1 in 1 BOTTLE	Historical