tizanidine

Product NDC: 71610-776
Requested package NDC: 71610-776-16
11-digit product format: 716100776
Labeler code: 71610
Product ID: 71610-776_2cee3817-e6f6-9db6-e063-6294a90a6ea1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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: 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
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 · 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	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…`
2019-12-13 00:20 UTC	2019-12	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`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	A076533-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076533-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076533-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076533-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076533-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076533-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076533-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076533-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076533-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076533-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076533-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076533-002	AB	1	`4b0b4de00fa7…`
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…`

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
ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7	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
71610-776-16	tizanidine	6000 in 1 BOTTLE	TABLET	6000	4
71610-776-30	tizanidine	30 in 1 BOTTLE	TABLET	30	4
71610-776-53	tizanidine	60 in 1 BOTTLE	TABLET	60	4
71610-776-60	tizanidine	90 in 1 BOTTLE	TABLET	90	4
71610-776-70	tizanidine	120 in 1 BOTTLE	TABLET	120	4
71610-776-75	tizanidine	7500 in 1 BOTTLE	TABLET	7500	4
71610-776-80	tizanidine	180 in 1 BOTTLE	TABLET	180	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-776-16	EA - Each	71610-776	a64c1457-f1e9-4dea-822c-04d74c2df476	1	2024-03-12
71610-776-30	EA - Each	71610-776	8c027ccd-98dd-459e-af1f-e38f2e5b8ca1	1	2024-03-12
71610-776-53	EA - Each	71610-776	c35550a1-beb8-435f-aebf-e3d6cccc6b2e	1	2024-03-12
71610-776-60	EA - Each	71610-776	710ce53a-88ce-47a2-beda-ae10d4e94f8c	1	2024-03-12
71610-776-70	EA - Each	71610-776	10848438-4e14-4986-96ab-5af8602189bb	1	2025-03-04
71610-776-75	EA - Each	71610-776	d7c53390-72ba-4aa8-9b20-22da2c8ecf9c	1	2024-05-16
71610-776-80	EA - Each	71610-776	dc1dc188-6eee-4aa3-98b4-36383cceadd2	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-776	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Current NDC, 7 package rows	20250205_ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7.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 · 7 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	Preferred Pharmaceuticals Inc.	f0e4eb26-6733-4df6-bb3c-86bf4d976f42	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Cardinal Health 107, LLC	eeb18068-75c8-42d0-a006-1b134648333f	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Apotex Corp.	01c0d3d3-2373-a1b7-822a-80a66291a248	2025-03-11	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 ndc (package): 71610-776-16 ndc (product): 71610-776 ndc11 (package): 71610077616
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
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	ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7	4
313413	tizanidine 4 MG Oral Tablet	SCD	ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7	4
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-776-16	71610077616	6000 TABLET in 1 BOTTLE (71610-776-16)	6000 tablet	2024-01-25	No	No	Current