Tolterodine tartrate

Product NDC: 27241-192
11-digit product format: 272410192
Labeler code: 27241
Product ID: 27241-192_cf018a04-660f-4119-898f-1877a5db8e7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA213397
Marketing category: ANDA
Marketing start: 2020-06-25
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
A213397-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-05-19
A213397-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213397-001	AB
A213397-002	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 · 74 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	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213397-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213397-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-19	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A213397-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213397-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213397-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213397-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213397-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213397-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213397-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213397-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213397-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213397-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213397-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213397-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213397-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213397-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213397-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213397-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213397-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213397-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213397-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213397-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213397-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213397-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213397-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213397-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213397-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213397-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213397-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213397-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213397-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213397-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213397-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213397-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213397-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213397-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213397-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213397-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213397-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213397-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213397-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213397-002	AB	1	`87673890dc5c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolterodine tartrate	TOLTERODINE TARTRATE	Ajanta Pharma USA Inc.	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213397 application number: ANDA213397 ndc (product): 27241-192

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 · 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
fcaca033-cd08-4b8c-9bad-7b6751faf2c9	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
27241-192-05	Tolterodine tartrate	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	5
27241-192-30	Tolterodine tartrate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	5
27241-192-90	Tolterodine tartrate	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-192-05	EA - Each	27241-192	f220a613-4745-44e8-b1d2-996b4be9883b	1	2020-09-14
27241-192-30	EA - Each	27241-192	639a1837-75b4-407c-b71e-81c44582728d	1	2020-09-14
27241-192-90	EA - Each	27241-192	db3807f9-93bb-441c-b578-56a6d3915d44	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-192	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [AJANTA PHARMA USA INC.]	4	Current NDC, Legacy NDC, 3 package rows	20211126_fcaca033-cd08-4b8c-9bad-7b6751faf2c9.zip

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	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	5
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	5
855182	24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule	SCD	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	5
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	5
855182	tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule	SY	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	5
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	fcaca033-cd08-4b8c-9bad-7b6751faf2c9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-192-05	27241019205	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-05)	2020-06-25	0000-00-00	No	No	Current
27241-192-30	27241019230	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-30)	2020-06-25	0000-00-00	No	No	Current
27241-192-90	27241019290	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-192-90)	2020-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolterodine tartrate	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan \| Ajanta Pharma Ltd., Dahej	2025-11-03	Human Prescription Drug Label	5