Tolterodine Tartrate

Product NDC: 0378-3402
11-digit product format: 003783402
Labeler code: 0378
Product ID: 0378-3402_03852abe-992e-4d0b-a105-19ca8faba01e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA201486
Marketing category: ANDA
Marketing start: 2013-10-31
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

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	0378-3402		D	Discontinued by firm	2026-08-17
excluded package	package	0378-3402	0378-3402-05	D	Discontinued by firm	2026-08-17
excluded package	package	0378-3402	0378-3402-93	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-3402-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-3402-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-3402-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-3402-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-3402-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-3402-93	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-3402-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-3402-93	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-3402-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-3402-93	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-3402-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-3402-93	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-3402-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-3402-93	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-3402-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-3402-93	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-3402-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-3402-93	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-3402-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-3402-93	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-3402-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-3402-93	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-3402-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-3402-93	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A201486-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL			2013-10-31
A201486-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL			2013-10-31

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	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201486-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201486-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-10-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201486-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201486-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201486-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201486-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201486-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201486-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201486-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201486-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201486-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201486-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201486-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201486-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201486-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201486-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201486-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201486-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3402-05	EA - Each	0378-3402	0f61f691-16e1-4c75-b8f4-a82319e539a3	1	2014-02-04
0378-3402-77	EA - Each	0378-3402	4c6b84de-06b6-4e7b-83a4-ee6409d634e9	1	2014-02-04
0378-3402-93	EA - Each	0378-3402	6ccba939-a946-4cea-a96d-e61188d1adab	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 CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
TOLTERODINE	ACTIVE MOIETY	WHE7A56U7K	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	3
TOLTERODINE TARTRATE	ACTIVE INGREDIENT	5T619TQR3R	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
TOLTERODINE	ACTIVE MOIETY	WHE7A56U7K	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	1

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3402-05	00378340205	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-05)	2013-10-31	0000-00-00	No	No	Current
0378-3402-93	00378340293	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-93)	2013-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolterodine Tartrate	Mylan Institutional Inc.	2020-01-10	HUMAN PRESCRIPTION DRUG LABEL	8
Tolterodine Tartrate	Golden State Medical Supply, Inc.	2019-12-02	HUMAN PRESCRIPTION DRUG LABEL	3
Tolterodine Tartrate	Mylan Pharmaceuticals Inc.	2018-08-17	HUMAN PRESCRIPTION DRUG LABEL	7