tizanidine

Product NDC: 68071-3719
11-digit product format: 680713719
Labeler code: 68071
Product ID: 68071-3719_2bae2620-0abb-7e55-e063-6394a90ad47c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA208187
Marketing category: ANDA
Marketing start: 2021-03-04
Substance: TIZANIDINE HYDROCHLORIDE
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
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
A208187-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2018-03-09
A208187-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2018-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208187-001	AB
A208187-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208187-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2018-03-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208187-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2018-03-09	`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	A208187-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208187-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208187-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208187-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208187-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208187-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208187-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208187-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208187-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208187-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208187-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208187-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208187-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208187-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208187-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208187-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208187-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208187-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208187-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208187-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208187-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208187-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208187-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208187-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208187-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208187-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208187-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208187-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208187-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: tizanidine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIZANIDINE HYDROCHLORIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B53E3NMY5C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313413	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
26cffb1f-21a0-017f-e063-6394a90afb1a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0ff02d8-b711-423c-b7d1-ada00d81c743	Product name	1	20250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01	Product name	8	20250313
b404127e-1c01-47bb-874e-db1e0b6bd9af	Product name	4	20250313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3719-3	tizanidine	30 in 1 BOTTLE	TABLET	30		2
68071-3719-9	tizanidine	90 in 1 BOTTLE	TABLET	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3719	TIZANIDINE TABLET [NUCARE PHARMACEUTICALS, INC.]	2	Current NDC, 2 package rows	20250116_26cffb1f-21a0-017f-e063-6394a90afb1a.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tizanidine	TIZANIDINE	REMEDYREPACK INC.	63b7eba3-6dea-4d89-bc42-7e965ae9795d	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Viona Pharmaceuticals Inc	8ac00d59-bb80-4530-afe7-90e04a2130b2	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Advanced Rx of Tennessee, LLC	30caf3b3-8c1b-268e-e063-6294a90a3c8a	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Coupler LLC	2d9a2492-d914-f87b-e063-6394a90a38c6	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	NuCare Pharmaceuticals, Inc.	26cffb1f-21a0-017f-e063-6394a90afb1a	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187 ndc (product): 68071-3719
Tizanidine	TIZANIDINE	Advanced Rx of Tennessee, LLC	21b7c8a8-ee07-a204-e063-6394a90a285b	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Asclemed USA, Inc.	a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d6	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Zydus Lifesciences Limited	89105a78-badb-469e-966e-195fa3a53f0a	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	Advanced Rx of Tennessee, LLC	2788942d-87fa-e514-e063-6294a90a0971	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187
tizanidine	TIZANIDINE	NCS HealthCare of KY, LLC dba Vangard Labs	c8278b4e-cca2-4880-8924-c8202ce084d6	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208187 application number: ANDA208187

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B53E3NMY5C	TIZANIDINE HYDROCHLORIDE	64461-82-1	TIZANIDINE HYDROCHLORIDE
6AI06C00GW	TIZANIDINE	51322-75-9	tizanidine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	26cffb1f-21a0-017f-e063-6394a90afb1a	2
313413	tizanidine 4 MG Oral Tablet	SCD	26cffb1f-21a0-017f-e063-6394a90afb1a	2
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	26cffb1f-21a0-017f-e063-6394a90afb1a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3719-3	68071371903	30 TABLET in 1 BOTTLE (68071-3719-3)	30 tablet	2024-11-13	No	No	Current
68071-3719-9	68071371909	90 TABLET in 1 BOTTLE (68071-3719-9)	90 tablet	2025-01-14	No	No	Current