TOLTERODINE TARTRATE

Product NDC: 0904-6593
Requested package NDC: 0904-6593-04
11-digit product format: 009046593
Labeler code: 0904
Product ID: 0904-6593_733b861b-8712-436e-a406-e14b640fd04c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOLTERODINE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA203016
Marketing category: ANDA
Marketing start: 2015-08-11
Marketing end: 2026-07-31
Substance: TOLTERODINE TARTRATE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-6593	0904-6593-04	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203016-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2015-08-11
A203016-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2015-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203016-001	AB
A203016-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203016-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203016-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2015-08-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203016-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203016-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203016-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203016-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203016-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203016-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203016-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203016-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203016-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203016-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203016-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203016-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203016-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203016-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203016-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203016-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203016-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203016-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203016-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203016-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203016-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203016-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203016-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203016-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203016-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203016-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203016-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203016-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203016-002	AB	1	`bb7c543d1eb4…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6593-04	TOLTERODINE TARTRATE	30 in 1 CARTON	CAPSULE, EXTENDED RELEASE	30		9
0904-6593-04	TOLTERODINE TARTRATE	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6593-04	EA - Each	0904-6593	15143612-785b-4b57-b235-1636c69bff20	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6593	TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20250515_da9423b5-00ab-46fc-8959-3db3c0a0bc6d.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	Torrent Pharmaceuticals Limited	db6e0b6d-0ce5-41d7-881f-881c11f530a4	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203016 application number: ANDA203016
Tolterodine Tartrate	TOLTERODINE	American Health Packaging	8cd23ff7-71ba-4391-95bd-a3a7f347713d	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203016 application number: ANDA203016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5T619TQR3R	TOLTERODINE TARTRATE	124937-52-6	TOLTERODINE TARTRATE
WHE7A56U7K	TOLTERODINE	124937-51-5	TOLTERODINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855182	tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule	PSN	da9423b5-00ab-46fc-8959-3db3c0a0bc6d	9
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	da9423b5-00ab-46fc-8959-3db3c0a0bc6d	9
855182	24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule	SCD	da9423b5-00ab-46fc-8959-3db3c0a0bc6d	9
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	da9423b5-00ab-46fc-8959-3db3c0a0bc6d	9
855182	tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule	SY	da9423b5-00ab-46fc-8959-3db3c0a0bc6d	9
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	da9423b5-00ab-46fc-8959-3db3c0a0bc6d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6593-04	00904659304	30 BLISTER PACK in 1 CARTON (0904-6593-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	30 blister pack	2015-08-11	2026-07-31	No	No	Current