Tolterodine Tartrate

Product NDC: 59762-0800
11-digit product format: 597620800
Labeler code: 59762
Product ID: 59762-0800_fdede630-529a-48fe-b796-59c3504c8d32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA020771
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-01-21
Marketing end: 2026-07-31
Substance: TOLTERODINE TARTRATE
Active strength: 2 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59762-0800		D	Discontinued by firm	2026-08-17
excluded package	package	59762-0800	59762-0800-2	D	Discontinued by firm	2026-08-17
excluded package	package	59762-0800	59762-0800-6	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
N020771-001	DETROL	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	RLD	1998-03-25
N020771-002	DETROL	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020771-001	AB
N020771-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020771-001	DETROL	1MG	TABLET / ORAL	AB	RLD	1998-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020771-002	DETROL	2MG	TABLET / ORAL	AB	RLD, RS	1998-03-25	`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	N020771-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020771-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020771-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020771-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020771-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020771-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020771-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020771-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020771-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020771-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020771-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020771-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020771-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020771-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020771-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020771-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020771-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020771-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020771-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020771-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020771-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020771-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020771-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020771-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020771-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020771-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020771-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020771-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020771-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020771-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020771-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020771-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020771-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020771-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020771-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020771-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020771-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020771-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020771-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020771-002	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
59762-0800-2	Tolterodine Tartrate	60 in 1 BOTTLE	TABLET, FILM COATED	60		12
59762-0800-6	Tolterodine Tartrate	500 in 1 BOTTLE	TABLET, FILM COATED	500		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-0800-2	EA - Each	59762-0800	065565e9-6ed0-41cf-b902-8ab03fa6d506	1	2014-02-04
59762-0800-6	EA - Each	59762-0800	5e5c556b-e179-451f-b122-af24272f8cc4	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLTERODINE TARTRATE	ACTIVE INGREDIENT	5T619TQR3R	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4
TOLTERODINE	ACTIVE MOIETY	WHE7A56U7K	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-0800	TOLTERODINE TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	11	Current NDC, Legacy NDC, 2 package rows	20250504_9e432622-2e6f-4cf8-892f-510288dd50f2.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	Mylan Pharmaceuticals Inc.	9e432622-2e6f-4cf8-892f-510288dd50f2	2024-09-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020771 application number: NDA020771 ndc (product): 59762-0800
Detrol	TOLTERODINE TARTRATE	Viatris Specialty LLC	41eb00d2-64e3-4ec9-8732-4bfc81b04180	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020771 application number: NDA020771

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
855178	tolterodine tartrate 1 MG Oral Tablet	PSN	9e432622-2e6f-4cf8-892f-510288dd50f2	12
855194	tolterodine tartrate 2 MG Oral Tablet	PSN	9e432622-2e6f-4cf8-892f-510288dd50f2	12
855178	tolterodine tartrate 1 MG Oral Tablet	SCD	9e432622-2e6f-4cf8-892f-510288dd50f2	12
855194	tolterodine tartrate 2 MG Oral Tablet	SCD	9e432622-2e6f-4cf8-892f-510288dd50f2	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-0800-2	59762080002	60 TABLET, FILM COATED in 1 BOTTLE (59762-0800-2)	2014-01-21	2026-06-30	No	No	Current
59762-0800-6	59762080006	500 TABLET, FILM COATED in 1 BOTTLE (59762-0800-6)	2014-01-21	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOLTERODINE TARTRATE TABLETS	Mylan Pharmaceuticals Inc.	2024-09-21	HUMAN PRESCRIPTION DRUG LABEL	12
Tolterodine Tartrate Tablets	REMEDYREPACK INC.	2022-07-18	HUMAN PRESCRIPTION DRUG LABEL	6