Tolterodine Tartrate

Product NDC: 70436-160
11-digit product format: 704360160
Labeler code: 70436
Product ID: 70436-160_44e07d95-cc64-cae9-e063-6294a90abc45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolterodine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Slate Run Pharmaceuticals, LLC
Application: ANDA213858
Marketing category: ANDA
Marketing start: 2021-04-12
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: 2026-12-31
Current FDA listing: Yes

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
A213858-001	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2021-02-02
A213858-002	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2021-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213858-001	AB
A213858-002	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 · 72 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	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213858-001	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213858-002	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-02-02	`782e0a99824c…`

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
2026-08-18 06:07:40	2026-07	A213858-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213858-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213858-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213858-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213858-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213858-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213858-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213858-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213858-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213858-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213858-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213858-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213858-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213858-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213858-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213858-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213858-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213858-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213858-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213858-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213858-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213858-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213858-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213858-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213858-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213858-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213858-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213858-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213858-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213858-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213858-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213858-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213858-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213858-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213858-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213858-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213858-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213858-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213858-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213858-002	AB	1	`782e0a99824c…`

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	2 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
bbbee85a-e5e2-24ec-e053-2995a90acfd8	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
70436-160-02	Tolterodine Tartrate	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	13
70436-160-04	Tolterodine Tartrate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	13
70436-160-06	Tolterodine Tartrate	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70436-160-02	EA - Each	70436-160	f5e19586-237e-4b35-b9a8-4960d4ad5137	1	2021-05-05
70436-160-04	EA - Each	70436-160	2c8c86f7-52b5-48df-8671-17513ad87671	1	2021-05-05
70436-160-06	EA - Each	70436-160	f53aeb28-0417-4499-90d5-d65d03eb380a	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70436-160	TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]	12	Current NDC, Legacy NDC, 3 package rows	20241120_bbbee85a-e5e2-24ec-e053-2995a90acfd8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolterodine Tartrate	TOLTERODINE TARTRATE	Slate Run Pharmaceuticals, LLC	bbbee85a-e5e2-24ec-e053-2995a90acfd8	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213858 application number: ANDA213858 ndc (product): 70436-160

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	bbbee85a-e5e2-24ec-e053-2995a90acfd8	13
855189	tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule	PSN	bbbee85a-e5e2-24ec-e053-2995a90acfd8	13
855182	24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule	SCD	bbbee85a-e5e2-24ec-e053-2995a90acfd8	13
855189	24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule	SCD	bbbee85a-e5e2-24ec-e053-2995a90acfd8	13
855182	tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule	SY	bbbee85a-e5e2-24ec-e053-2995a90acfd8	13
855189	tolterodine tartrate 4 MG 24 HR Extended Release Oral Capsule	SY	bbbee85a-e5e2-24ec-e053-2995a90acfd8	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70436-160-02	70436016002	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-160-02)	2021-04-12	0000-00-00	No	No	Current
70436-160-04	70436016004	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-160-04)	2021-04-12	0000-00-00	No	No	Current
70436-160-06	70436016006	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-160-06)	2021-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolterodine Tartrate	Slate Run Pharmaceuticals, LLC \| Yichang Humanwell Oral Solid Dosage Plant	2026-08-05	HUMAN PRESCRIPTION DRUG LABEL	14