Tolterodine Tartrate

Product NDC: 50090-3475
Requested package NDC: 50090-3475-1
11-digit product format: 500903475
Labeler code: 50090
Product ID: 50090-3475_9031ca7e-ead2-404d-a98e-d8dbd2eff0d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA079141
Marketing category: ANDA
Marketing start: 2017-03-20
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079141-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-11-22
A079141-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-11-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A079141-001	AB
A079141-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079141-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079141-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079141-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079141-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079141-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079141-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079141-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079141-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079141-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079141-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079141-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079141-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079141-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079141-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079141-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079141-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079141-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079141-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079141-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079141-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079141-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079141-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079141-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079141-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079141-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079141-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079141-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079141-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079141-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079141-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079141-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079141-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079141-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079141-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079141-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079141-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079141-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079141-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079141-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079141-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079141-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079141-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLTERODINE TARTRATE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5T619TQR3R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855189	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fd6c8b3d-a52a-4418-aa9c-0297db6c0807	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-3475-0	2023-02-06	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
50090-3475-0	2023-02-06	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
50090-3475-1	2023-02-06	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
50090-3475-1	2023-02-06	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
50090-3475-0	2023-01-30	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
50090-3475-0	2023-01-30	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
50090-3475-1	2023-01-30	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
50090-3475-1	2023-01-30	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3475-0	Tolterodine Tartrate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		15
50090-3475-1	Tolterodine Tartrate	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3475-1	EA - Each	50090-3475	37169476-d7bd-4526-bff1-14cea4a4db7b	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3475	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	13	Current NDC, Legacy NDC, 2 package rows	20230806_fd6c8b3d-a52a-4418-aa9c-0297db6c0807.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolterodine Tartrate	TOLTERODINE TARTRATE	A-S Medication Solutions	fd6c8b3d-a52a-4418-aa9c-0297db6c0807	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079141 application number: ANDA079141 ndc (package): 50090-3475-1 ndc (product): 50090-3475 ndc11 (package): 50090347501
Tolterodine Tartrate	TOLTERODINE TARTRATE	Teva Pharmaceuticals USA, Inc.	973f98b5-4e8a-42d9-ac69-d4333d21c362	2024-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079141 application number: ANDA079141

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	fd6c8b3d-a52a-4418-aa9c-0297db6c0807	15
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	fd6c8b3d-a52a-4418-aa9c-0297db6c0807	15
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	fd6c8b3d-a52a-4418-aa9c-0297db6c0807	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3475-1	50090347501	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3475-1)	2018-06-14	0000-00-00	No	No	Current