Tizanidine

Product NDC: 57664-503
11-digit product format: 576640503
Labeler code: 57664
Product ID: 57664-503_5e8ef5b3-9f58-46a7-833c-31ef018ea9a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA076416
Marketing category: ANDA
Marketing start: 2003-12-11
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 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
A076416-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2003-09-29
A076416-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2003-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076416-001	AB
A076416-002	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 · 82 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	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A076416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076416-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076416-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076416-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076416-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076416-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076416-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076416-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076416-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076416-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076416-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076416-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076416-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076416-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076416-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076416-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076416-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076416-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076416-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076416-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076416-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076416-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076416-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076416-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076416-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076416-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076416-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076416-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076416-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313412	Internal RxNorm lookup
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
4659df31-8b89-4eff-9d86-7b7e38de416b	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
57664-503-18	Tizanidine	1000 in 1 BOTTLE	TABLET	1000		9
57664-503-89	Tizanidine	150 in 1 BOTTLE	TABLET	150		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-503-13	EA - Each	57664-503	59c52ed5-491e-40c4-ac95-b8ece7f27eb1	1	2012-07-24
57664-503-18	EA - Each	57664-503	a018f0c4-88ae-4fd7-b1ba-40f719e56f02	1	2012-07-24
57664-503-83	EA - Each	57664-503	a478ffde-beef-44f3-ac09-bcc953752dc1	1	2012-07-24
57664-503-88	EA - Each	57664-503	bf01783f-a12a-4fc3-a1d2-0e8f21c7f2ef	1	2012-07-24
57664-503-89	EA - Each	57664-503	6ad6f4c9-2594-4909-b656-38d0eaf517b6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [AVKARE, INC.]	2
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [AVKARE, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [AVKARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [AVKARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TIZANIDINE TABLET [AVKARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [AVKARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-503	TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20201010_4659df31-8b89-4eff-9d86-7b7e38de416b.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	25db7cc0-604c-3d6b-e063-6394a90a337f	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Medcore LLC	14bcfbac-8f6a-42af-b3a4-ba10d99f2468	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	f041e5f7-c138-4622-98bf-881f9a649a26	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	fefe8332-32eb-4b81-978f-b23b334d7d57	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Northwind Health Company, LLC	f32f399f-42af-f0ba-e053-2a95a90a8c2e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	PD-Rx Pharmaceuticals, Inc.	fd16a25c-67b6-ae6c-e053-6394a90aeee0	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	PD-Rx Pharmaceuticals, Inc.	fdf4f09d-4537-a438-e053-6394a90a573d	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	73269d77-16b5-4787-9a7d-1b8688623436	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Asclemed USA, Inc.	2f460275-565f-4737-a3df-bf80b9acc268	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Direct_rx	2a91884a-39c3-f7ac-e063-6394a90ade14	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine HCL	TIZANIDINE HCL	Advanced Rx of Tennessee, LLC	af73c6ab-6c1c-94d1-e053-2a95a90a4e3c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	e13292b0-9858-4405-8787-a2392d1b6d75	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	5f8a5b21-4adb-4f2c-91ae-bc33c3810752	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	dd3bf952-50b1-4d50-9073-57fd6888053b	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	81501cb1-0a76-4bd0-8eee-dbd1e4a0b69f	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	51da17a0-63d2-44fb-a79d-a3bee862e028	2023-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	03fa03a6-fd05-4f17-872a-3c123330935d	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	5a5b6614-038f-4e5b-9543-0497872c7882	2023-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Proficient Rx LP	76dc85bd-3cde-4940-a99b-663b70bf9f54	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416
Tizanidine	TIZANIDINE	Proficient Rx LP	20424d92-5ca1-4114-bc51-1f07c3bed6be	2021-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076416 application number: ANDA076416

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	dd3bf952-50b1-4d50-9073-57fd6888053b	103
313413	tizanidine 4 MG Oral Tablet	SCD	dd3bf952-50b1-4d50-9073-57fd6888053b	103
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	dd3bf952-50b1-4d50-9073-57fd6888053b	103
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	51da17a0-63d2-44fb-a79d-a3bee862e028	101
313413	tizanidine 4 MG Oral Tablet	SCD	51da17a0-63d2-44fb-a79d-a3bee862e028	101
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	51da17a0-63d2-44fb-a79d-a3bee862e028	101
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	fd16a25c-67b6-ae6c-e053-6394a90aeee0	20
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	fd16a25c-67b6-ae6c-e053-6394a90aeee0	20
313412	tizanidine 2 MG Oral Tablet	SCD	fd16a25c-67b6-ae6c-e053-6394a90aeee0	20
313413	tizanidine 4 MG Oral Tablet	SCD	fd16a25c-67b6-ae6c-e053-6394a90aeee0	20
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	fd16a25c-67b6-ae6c-e053-6394a90aeee0	20
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	fd16a25c-67b6-ae6c-e053-6394a90aeee0	20
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	cf0dca9d-37ff-4c21-a5cc-56d4839d4d35	16
313413	tizanidine 4 MG Oral Tablet	SCD	cf0dca9d-37ff-4c21-a5cc-56d4839d4d35	16
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	cf0dca9d-37ff-4c21-a5cc-56d4839d4d35	16
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	fdf4f09d-4537-a438-e053-6394a90a573d	12
313413	tizanidine 4 MG Oral Tablet	SCD	fdf4f09d-4537-a438-e053-6394a90a573d	12
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	fdf4f09d-4537-a438-e053-6394a90a573d	12
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	4659df31-8b89-4eff-9d86-7b7e38de416b	9
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	4659df31-8b89-4eff-9d86-7b7e38de416b	9
313412	tizanidine 2 MG Oral Tablet	SCD	4659df31-8b89-4eff-9d86-7b7e38de416b	9
313413	tizanidine 4 MG Oral Tablet	SCD	4659df31-8b89-4eff-9d86-7b7e38de416b	9
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	4659df31-8b89-4eff-9d86-7b7e38de416b	9
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	4659df31-8b89-4eff-9d86-7b7e38de416b	9
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	af73c6ab-6c1c-94d1-e053-2a95a90a4e3c	6
313413	tizanidine 4 MG Oral Tablet	SCD	af73c6ab-6c1c-94d1-e053-2a95a90a4e3c	6
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	af73c6ab-6c1c-94d1-e053-2a95a90a4e3c	6
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	76dc85bd-3cde-4940-a99b-663b70bf9f54	5
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	03fa03a6-fd05-4f17-872a-3c123330935d	5
313413	tizanidine 4 MG Oral Tablet	SCD	76dc85bd-3cde-4940-a99b-663b70bf9f54	5
313413	tizanidine 4 MG Oral Tablet	SCD	03fa03a6-fd05-4f17-872a-3c123330935d	5
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	03fa03a6-fd05-4f17-872a-3c123330935d	5
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	76dc85bd-3cde-4940-a99b-663b70bf9f54	5
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	2a91884a-39c3-f7ac-e063-6394a90ade14	3
313413	tizanidine 4 MG Oral Tablet	SCD	2a91884a-39c3-f7ac-e063-6394a90ade14	3
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	2a91884a-39c3-f7ac-e063-6394a90ade14	3
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	f32f399f-42af-f0ba-e053-2a95a90a8c2e	2
313413	tizanidine 4 MG Oral Tablet	SCD	f32f399f-42af-f0ba-e053-2a95a90a8c2e	2
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	f32f399f-42af-f0ba-e053-2a95a90a8c2e	2
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	2f460275-565f-4737-a3df-bf80b9acc268	1
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	d646e3e1-d611-4c23-9ded-b327e4acfe4f	1
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	fefe8332-32eb-4b81-978f-b23b334d7d57	1
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	2f460275-565f-4737-a3df-bf80b9acc268	1
313412	tizanidine 2 MG Oral Tablet	SCD	2f460275-565f-4737-a3df-bf80b9acc268	1
313413	tizanidine 4 MG Oral Tablet	SCD	2f460275-565f-4737-a3df-bf80b9acc268	1
313413	tizanidine 4 MG Oral Tablet	SCD	d646e3e1-d611-4c23-9ded-b327e4acfe4f	1
313413	tizanidine 4 MG Oral Tablet	SCD	fefe8332-32eb-4b81-978f-b23b334d7d57	1
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	2f460275-565f-4737-a3df-bf80b9acc268	1
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	2f460275-565f-4737-a3df-bf80b9acc268	1
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	fefe8332-32eb-4b81-978f-b23b334d7d57	1
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	d646e3e1-d611-4c23-9ded-b327e4acfe4f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-503-18	57664050318	1000 TABLET in 1 BOTTLE (57664-503-18)	1000 tablet	2003-12-11	0000-00-00	No	No	Current
57664-503-89	57664050389	150 TABLET in 1 BOTTLE (57664-503-89)	150 tablet	2003-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tizanidine	Bryant Ranch Prepack	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	1
Tizanidine	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Tizanidine	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	20
Tizanidine	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	12
Tizanidine	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-05-02	HUMAN PRESCRIPTION DRUG LABEL	1
Tizanidine	Direct_rx	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	3
Tizanidine HCL Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Tizanidine	AvKARE	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	7
Tizanidine	Bryant Ranch Prepack	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	103
Tizanidine	Bryant Ranch Prepack	2023-11-29	HUMAN PRESCRIPTION DRUG LABEL	101
Tizanidine	Bryant Ranch Prepack	2023-11-09	HUMAN PRESCRIPTION DRUG LABEL	5
Tizanidine	REMEDYREPACK INC.	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	7
Tizanidine	NCS HealthCare of KY, LLC dba Vangard Labs	2023-02-24	HUMAN PRESCRIPTION DRUG LABEL	5
Tizanidine	Proficient Rx LP	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL	5
Tizanidine	Preferred Pharmaceuticals Inc.	2021-09-21	HUMAN PRESCRIPTION DRUG LABEL	5
Tizanidine	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	16
Tizanidine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	2
Tizanidine	Sun Pharmaceutical Industries, Inc. \| ALKALOIDA chemical company Zrt	2020-10-09	HUMAN PRESCRIPTION DRUG LABEL	9
Tizanidine	Major Pharmaceuticals	2019-06-05	HUMAN PRESCRIPTION DRUG LABEL	1
Tizanidine	Aidarex Pharmaceuticals LLC	2016-12-09	HUMAN PRESCRIPTION DRUG LABEL	1