Tizanidine

Product NDC: 43353-914
Requested package NDC: 43353-914-56
11-digit product format: 433530914
Labeler code: 43353
Product ID: 43353-914_39bfe789-da22-4c5e-ac9e-3e90f2ba1c21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076354
Marketing category: ANDA
Marketing start: 2003-05-06
Marketing end: 2021-02-28
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: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-914	43353-914-56	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076354-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2003-03-28
A076354-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2003-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076354-001	AB
A076354-002	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	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2003-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2003-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076354-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2003-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076354-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2003-03-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076354-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076354-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076354-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076354-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076354-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076354-002	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A076354-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076354-002	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A076354-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076354-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076354-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076354-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076354-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076354-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076354-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076354-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076354-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076354-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076354-002	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076354-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076354-002	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-914-16	EA - Each	43353-914	4e0943e5-4f19-40c1-8b32-38f9c2c686df	1	2015-01-05
43353-914-30	EA - Each	43353-914	d50fa4a9-8e1a-44fb-a20f-b0d4bb8a88ed	1	2017-11-06
43353-914-53	EA - Each	43353-914	d85d9d72-1612-48b9-aa5c-84d1d58667c9	1	2017-11-06
43353-914-60	EA - Each	43353-914	924d054f-e559-492c-abc6-250db39562b0	1	2017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

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
43353-914-56	43353091456	3000 TABLET in 1 BOTTLE, PLASTIC (43353-914-56)	3000 tablet	2016-12-12	2021-02-28	No	No	Current