Tolterodine Tartrate

Product NDC: 43975-322
11-digit product format: 439750322
Labeler code: 43975
Product ID: 43975-322_361c4d47-0750-6f78-e063-6394a90ab0c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA204562
Marketing category: ANDA
Marketing start: 2019-08-29
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

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
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 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
2026-08-18 06:07:40	2026-07	A204562-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204562-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2019-08-19	`caaa826d4ba7…`
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…`

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
2026-08-18 06:07:40	2026-07	A204562-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204562-002	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tolterodine Tartrate
Listing expiration: 2026-12-31

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
fc5bdc4a-a483-4d31-807b-c7f8d8869723	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
a932c194-3a9e-a7d8-8961-eb5843129c16	Product name	6	20220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43975-322-03	Tolterodine Tartrate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	4
43975-322-09	Tolterodine Tartrate	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	4
43975-322-50	Tolterodine Tartrate	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43975-322-03	EA - Each	43975-322	5aa81290-bd2e-4657-a14e-97f54b662c85	1	2020-04-20
43975-322-09	EA - Each	43975-322	7d1187fd-9a26-42cb-9b6d-47f4ef4d674f	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43975-322	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20231219_fc5bdc4a-a483-4d31-807b-c7f8d8869723.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 · 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
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 ndc (product): 43975-322

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
855182	tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule	PSN	05b92da2-923b-3c04-e063-6394a90a69a1	5
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	05b92da2-923b-3c04-e063-6394a90a69a1	5
855182	24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule	SCD	05b92da2-923b-3c04-e063-6394a90a69a1	5
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	05b92da2-923b-3c04-e063-6394a90a69a1	5
855182	tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule	SY	05b92da2-923b-3c04-e063-6394a90a69a1	5
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	05b92da2-923b-3c04-e063-6394a90a69a1	5
855182	tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule	PSN	fc5bdc4a-a483-4d31-807b-c7f8d8869723	4
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	fc5bdc4a-a483-4d31-807b-c7f8d8869723	4
855182	24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule	SCD	fc5bdc4a-a483-4d31-807b-c7f8d8869723	4
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	fc5bdc4a-a483-4d31-807b-c7f8d8869723	4
855182	tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule	SY	fc5bdc4a-a483-4d31-807b-c7f8d8869723	4
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	fc5bdc4a-a483-4d31-807b-c7f8d8869723	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43975-322-03	43975032203	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-03)	2019-08-29	0000-00-00	No	No	Current
43975-322-09	43975032209	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-09)	2019-08-29	0000-00-00	No	No	Current
43975-322-50	43975032250	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-50)	2019-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolterodine Tartrate	Major Pharmaceuticals	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
Tolterodine Tartrate	Golden State Medical Supply, Inc.	2026-01-06	HUMAN PRESCRIPTION DRUG LABEL	5
Tolterodine Tartrate	ANI Pharmaceuticals, Inc.	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	4