tizanidine

Product NDC: 63187-145
11-digit product format: 631870145
Labeler code: 63187
Product ID: 63187-145_fa1c80fd-e646-4850-8f31-04c5417978c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076533
Marketing category: ANDA
Marketing start: 2004-01-16
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076533-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2004-01-16
A076533-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2004-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076533-001	AB
A076533-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076533-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076533-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076533-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076533-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076533-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076533-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076533-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076533-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076533-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076533-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076533-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076533-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076533-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076533-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076533-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076533-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076533-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076533-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076533-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076533-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076533-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076533-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076533-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076533-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076533-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076533-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076533-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076533-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076533-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076533-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076533-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076533-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076533-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076533-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076533-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076533-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076533-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076533-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076533-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076533-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: tizanidine
Listing expiration: 2027-12-31

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
cf77e63c-a62a-43fc-8705-0558925e04e8	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	SPL version
63187-145-30	tizanidine	30 in 1 BOTTLE	TABLET	30	6
63187-145-60	tizanidine	60 in 1 BOTTLE	TABLET	60	6
63187-145-90	tizanidine	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-145-30	EA - Each	63187-145	8d27c38b-a32f-45a2-a972-2b2961b32429	1	2015-10-02
63187-145-60	EA - Each	63187-145	93757921-f848-4002-99ec-e187b97f571d	1	2015-03-03
63187-145-90	EA - Each	63187-145	00d48a80-75c6-4eff-9a61-5d16e6eec639	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
tizanidine hydrochloride	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [PROFICIENT RX LP]	3
Tizanidine	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [PROFICIENT RX LP]	3
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [PROFICIENT RX LP]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [PROFICIENT RX LP]	3
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [PROFICIENT RX LP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-145	TIZANIDINE TABLET [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 3 package rows	20220726_cf77e63c-a62a-43fc-8705-0558925e04e8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tizanidine	TIZANIDINE	Major Pharmaceuticals	d24e0cda-a22f-404f-b861-f85090cef099	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Proficient Rx LP	cf77e63c-a62a-43fc-8705-0558925e04e8	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533 ndc (product): 63187-145
tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	d3b8d863-d13d-467c-97bf-5db9708036db	2020-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533

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	cf77e63c-a62a-43fc-8705-0558925e04e8	6
313413	tizanidine 4 MG Oral Tablet	SCD	cf77e63c-a62a-43fc-8705-0558925e04e8	6
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	cf77e63c-a62a-43fc-8705-0558925e04e8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-145-30	63187014530	30 TABLET in 1 BOTTLE (63187-145-30)	30 tablet	2019-01-01	0000-00-00	No	No	Current
63187-145-60	63187014560	60 TABLET in 1 BOTTLE (63187-145-60)	60 tablet	2019-01-01	0000-00-00	No	No	Current
63187-145-90	63187014590	90 TABLET in 1 BOTTLE (63187-145-90)	90 tablet	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TIZANIDINE TABLETS, USP 4 mg (base) Rx Only	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	6