Tolterodine Tartarate

Product NDC: 73152-027
11-digit product format: 731520027
Labeler code: 73152
Product ID: 73152-027_d69591ec-08f2-7990-e053-2a95a90a1bf0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartarate
Dosage form: TABLET
Route: ORAL
Labeler: Athem LLC
Application: ANDA210775
Marketing category: ANDA
Marketing start: 2020-08-03
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: 2023-12-31
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	73152-027		I	Inactivated by FDA	2026-08-03
excluded package	package	73152-027	73152-027-05	I	Inactivated by FDA	2026-08-03
excluded package	package	73152-027	73152-027-60	I	Inactivated by FDA	2026-08-03

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
A210775-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB		2019-12-30
A210775-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB		2019-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210775-001	AB
A210775-002	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	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210775-001	TOLTERODINE TARTRATE	1MG	TABLET / ORAL	AB	2019-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210775-002	TOLTERODINE TARTRATE	2MG	TABLET / ORAL	AB	2019-12-30	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A210775-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210775-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210775-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210775-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210775-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210775-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210775-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210775-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210775-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210775-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210775-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210775-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210775-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210775-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210775-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210775-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210775-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210775-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210775-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210775-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210775-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210775-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210775-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210775-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210775-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210775-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210775-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210775-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210775-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210775-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210775-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210775-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210775-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210775-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210775-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210775-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210775-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210775-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210775-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210775-002	AB	1	`87673890dc5c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73152-027-05	2026-01-29	C162847	48780-1	49896155-b595-586f-e063-e6dba90add90	Tolterodine Tartrate Tablets
73152-027-60	2026-01-29	C162847	48780-1	49896155-b595-586f-e063-e6dba90add90	Tolterodine Tartrate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73152-027-05	Tolterodine Tartarate	500 in 1 BOTTLE	TABLET	500		4
73152-027-60	Tolterodine Tartarate	60 in 1 BOTTLE	TABLET	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73152-027-05	EA - Each	73152-027	76834704-301d-47e8-8c7c-5ea9a12386c0	1	2021-04-08
73152-027-60	EA - Each	73152-027	c71cd774-1e76-4598-936c-1a6346dba34c	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73152-027	TOLTERODINE TARTRATE TABLET TOLTERODINE TARTARATE TABLET [ATHEM LLC]	4	Legacy NDC, 2 package rows	20230324_ab35eeae-d23a-505b-e053-2a95a90a005a.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
855178	tolterodine tartrate 1 MG Oral Tablet	PSN	ab35eeae-d23a-505b-e053-2a95a90a005a	4
855194	tolterodine tartrate 2 MG Oral Tablet	PSN	ab35eeae-d23a-505b-e053-2a95a90a005a	4
855178	tolterodine tartrate 1 MG Oral Tablet	SCD	ab35eeae-d23a-505b-e053-2a95a90a005a	4
855194	tolterodine tartrate 2 MG Oral Tablet	SCD	ab35eeae-d23a-505b-e053-2a95a90a005a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73152-027-05	73152002705	500 TABLET in 1 BOTTLE (73152-027-05)	500 tablet	2020-08-03	0000-00-00	No	No	Current
73152-027-60	73152002760	60 TABLET in 1 BOTTLE (73152-027-60)	60 tablet	2020-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolterodine Tartrate Tablets	Athem LLC \| Invatech Pharma Solutions LLC	2023-03-23	HUMAN PRESCRIPTION DRUG LABEL	4