Tizanidine

Product NDC: 71610-167
11-digit product format: 716100167
Labeler code: 71610
Product ID: 71610-167_a03d5407-7fe3-4064-a9cc-bda2f20e1a51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076416
Marketing category: ANDA
Marketing start: 2015-07-28
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-167		D	Discontinued by firm	2026-08-17
excluded package	package	71610-167	71610-167-30	D	Discontinued by firm	2026-08-17
excluded package	package	71610-167	71610-167-53	D	Discontinued by firm	2026-08-17
excluded package	package	71610-167	71610-167-60	D	Discontinued by firm	2026-08-17

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
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 · 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	A076416-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076416-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-09-29	`caaa826d4ba7…`
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…`

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	A076416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076416-002	AB	1	`caaa826d4ba7…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-167-30	EA - Each	71610-167	ebe6ad27-0a7f-47ac-a658-06fced1ee0bd	1	2018-12-13
71610-167-53	EA - Each	71610-167	4af090ee-49d1-4f2a-8cb4-f1216e7616b2	1	2018-12-13
71610-167-60	EA - Each	71610-167	ee8713d7-f7a9-4b2b-ad9d-da69a1f23197	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-167	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20181023_0ad36479-2ff0-40fb-b9cf-6baa35b19184.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-167-30	71610016730	30 TABLET in 1 BOTTLE (71610-167-30)	30 tablet	2018-10-08	0000-00-00	No	No	Current
71610-167-53	71610016753	60 TABLET in 1 BOTTLE (71610-167-53)	60 tablet	2018-10-05	0000-00-00	No	No	Current
71610-167-60	71610016760	90 TABLET in 1 BOTTLE (71610-167-60)	90 tablet	2018-10-05	0000-00-00	No	No	Current