Tolterodine Tartrate

Product NDC: 0093-2049
11-digit product format: 000932049
Labeler code: 0093
Product ID: 0093-2049_95042583-c90a-40a9-98e1-bdd849df6e8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Teva Pharmaceuticals USA Inc
Application: NDA021228
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-01-02
Marketing end: 0000-00-00
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: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0093-2049		D	Discontinued by firm	2026-08-17
excluded package	package	0093-2049	0093-2049-05	D	Discontinued by firm	2026-08-17
excluded package	package	0093-2049	0093-2049-56	D	Discontinued by firm	2026-08-17
excluded package	package	0093-2049	0093-2049-98	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 · 48 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	0093-2049-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-2049-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-2049-98	`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	0093-2049-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-2049-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-2049-98	`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	0093-2049-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-2049-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-2049-98	`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	0093-2049-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-2049-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-2049-98	`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	0093-2049-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-2049-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-2049-98	`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	0093-2049-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-2049-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-2049-98	`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	0093-2049-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-2049-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-2049-98	`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	0093-2049-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-2049-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-2049-98	`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	0093-2049-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-2049-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-2049-98	`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	0093-2049-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-2049-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-2049-98	`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	0093-2049-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-2049-56	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-2049-98	`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	0093-2049-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-2049-56	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-2049-98	`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
N021228-001	DETROL LA	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22
N021228-002	DETROL LA	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021228-001	AB
N021228-002	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	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021228-001	DETROL LA	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2000-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021228-002	DETROL LA	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-12-22	`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	N021228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021228-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021228-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021228-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021228-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021228-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021228-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021228-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021228-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021228-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021228-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021228-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021228-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021228-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021228-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021228-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021228-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021228-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021228-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021228-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021228-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021228-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021228-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021228-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021228-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021228-001	6770295	2019-08-26	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6630162	2019-11-11	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6911217	2019-11-11	U-544	Drug product	2013-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6770295	2019-08-26	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6630162	2019-11-11	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6911217	2019-11-11	U-544	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6770295	2019-08-26	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6630162	2019-11-11	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6911217	2019-11-11	U-544	Drug product	2013-04-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6630162*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-001	6911217*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6770295	2019-08-26	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6630162	2019-11-11	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6911217	2019-11-11	U-544	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6770295*PED	2020-02-26		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6630162*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021228-002	6911217*PED	2020-05-11		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6770295	2019-08-26	U-544	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6630162	2019-11-11	U-544	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6911217	2019-11-11	U-544	Drug product	2013-04-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021228-001	6770295*PED	2020-02-26		Pediatric extension		`b00525d2431f…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-2049-05	EA - Each	0093-2049	df7db28b-cd44-454a-9e03-ea36c7df4e4e	1	2014-02-04
0093-2049-56	EA - Each	0093-2049	32475ba6-16d6-4c83-b932-890aa92d5d43	1	2014-02-04
0093-2049-98	EA - Each	0093-2049	7cc1badd-bef1-4908-9c04-61df702f3299	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TOLTERODINE TARTRATE	ACTIVE INGREDIENT	5T619TQR3R	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5
TOLTERODINE	ACTIVE MOIETY	WHE7A56U7K	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	5

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	09b4ec42-9b47-4a6c-b219-7c5dcda35ac5	4
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	09b4ec42-9b47-4a6c-b219-7c5dcda35ac5	4
855182	24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule	SCD	09b4ec42-9b47-4a6c-b219-7c5dcda35ac5	4
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	09b4ec42-9b47-4a6c-b219-7c5dcda35ac5	4
855182	tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule	SY	09b4ec42-9b47-4a6c-b219-7c5dcda35ac5	4
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	09b4ec42-9b47-4a6c-b219-7c5dcda35ac5	4
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	ca4b3a0e-0f80-44e7-8cad-587610c6f198	2
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	ca4b3a0e-0f80-44e7-8cad-587610c6f198	2
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	ca4b3a0e-0f80-44e7-8cad-587610c6f198	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolterodine Tartrate	Teva Pharmaceuticals USA Inc	2018-08-21	HUMAN PRESCRIPTION DRUG LABEL	7
Tolterodine Tartrate	Carilion Materials Management	2017-12-26	HUMAN PRESCRIPTION DRUG LABEL	4
Tolterodine Tartrate	Carilion Materials Management	2016-06-17	HUMAN PRESCRIPTION DRUG LABEL	2