Tolterodine Tartrate

Product NDC: 0904-7574
Requested package NDC: 0904-7574-04
11-digit product format: 009047574
Labeler code: 0904
Product ID: 0904-7574_e4b9ef09-c750-4e35-96fc-e759ba4849d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA204562
Marketing category: ANDA
Marketing start: 2026-06-24
Substance: TOLTERODINE TARTRATE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]
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
A204562-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-08-19
A204562-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204562-001	AB
A204562-002	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 2 · 80 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	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A204562-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204562-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204562-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204562-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204562-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204562-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204562-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204562-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204562-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204562-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204562-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204562-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204562-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204562-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204562-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204562-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204562-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204562-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204562-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204562-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204562-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204562-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204562-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204562-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204562-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204562-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204562-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204562-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204562-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204562-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204562-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204562-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204562-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204562-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204562-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204562-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204562-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204562-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204562-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204562-002	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	2 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855182	Internal RxNorm lookup
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
e4b9ef09-c750-4e35-96fc-e759ba4849d8	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolterodine Tartrate	TOLTERODINE TARTRATE	Major Pharmaceuticals	e4b9ef09-c750-4e35-96fc-e759ba4849d8	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204562 application number: ANDA204562 ndc (package): 0904-7574-04 ndc (product): 0904-7574 ndc11 (package): 00904757404
Tolterodine Tartrate	TOLTERODINE TARTRATE	Golden State Medical Supply, Inc.	05b92da2-923b-3c04-e063-6394a90a69a1	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204562 application number: ANDA204562
Tolterodine Tartrate	TOLTERODINE TARTRATE	ANI Pharmaceuticals, Inc.	fc5bdc4a-a483-4d31-807b-c7f8d8869723	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204562 application number: ANDA204562

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
0904-7574-04	00904757404	30 BLISTER PACK in 1 CARTON (0904-7574-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	30 blister pack	2026-06-24	0	Current