Tizanidine

Product NDC: 53217-344
11-digit product format: 532170344
Labeler code: 53217
Product ID: 53217-344_26758b13-8299-479f-996a-0ef4dbe0bd9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA091283
Marketing category: ANDA
Marketing start: 2017-11-28
Marketing end: 0000-00-00
Substance: TIZANIDINE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53217-344		I	Inactivated by FDA		2026-08-11
excluded package	package	53217-344	53217-344-30	I	Inactivated by FDA		2026-08-11

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-344-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-344-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-344-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-344-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-344-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-344-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-344-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-344-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-344-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-344-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-344-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-344-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-344-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-344-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-344-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-344-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-344-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-344-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-344-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-344-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-344-30	`9bebd1f3094a…`	`5416666fcb17…`

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
A091283-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2012-11-28
A091283-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2012-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091283-001	AB
A091283-002	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	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091283-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091283-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`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	A091283-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091283-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091283-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091283-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091283-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091283-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091283-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091283-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091283-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091283-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091283-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091283-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091283-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091283-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091283-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091283-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091283-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091283-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091283-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091283-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091283-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091283-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091283-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091283-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091283-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091283-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091283-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091283-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091283-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-344-30	2020-01-31	C162847	48780-1	9d75b9d0-8f35-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-344-30	Tizanidine	30 in 1 BOTTLE, PLASTIC	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-344	TIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180815_a3b676eb-c097-46f5-ba16-fd1dedf2f5eb.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	NuCare Pharmaceuticals,Inc.	6dd9946f-b2a4-1732-e053-2a91aa0a648f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	b14bd166-9f53-4f2e-be05-c447af04ef69	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	047c67cd-7a63-49c9-b100-71651d3537ba	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
TIZANDINE	TIZANDINE	Direct_Rx	9003cb5d-f9d6-7183-e053-2995a90ad6e8	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	A-S Medication Solutions	308d2fdc-6136-4e75-95d3-342497add66c	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	A-S Medication Solutions	9fd932fb-033c-4774-ac09-c823db8f9739	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Redpharm Drug	49adcfc8-3b1d-7f7e-e063-6294a90a361e	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	PD-Rx Pharmaceuticals, Inc.	615dfd5c-125a-40e2-a6da-afacde305282	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Unichem Pharmaceuticals (USA), Inc.	a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	A-S Medication Solutions	9678a98e-4aab-4d87-b5e1-37c3109e378e	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	f87e30ce-a60a-41e3-b5d6-7e2966143961	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals Inc.	6e97c1ba-8171-4707-98ee-61afed75daac	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine HCL	TIZANIDINE HCL	Advanced Rx of Tennessee, LLC	afc96ee6-c99b-7283-e053-2a95a90ad14d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Advanced Rx Pharmacy of Tennessee, LLC	d2961d1c-5de2-0a2b-e053-2995a90ad2fc	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Proficient Rx LP	e13b111a-25b7-4fdd-a102-30f2996722f3	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Proficient Rx LP	5b7b4721-e6fa-4586-ac40-091ad363ee85	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283
Tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	ea242c7d-b101-4197-8e65-b2b079e3b2b6	2019-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091283 application number: ANDA091283

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
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	a3b676eb-c097-46f5-ba16-fd1dedf2f5eb	1
313412	tizanidine 2 MG Oral Tablet	SCD	a3b676eb-c097-46f5-ba16-fd1dedf2f5eb	1
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	a3b676eb-c097-46f5-ba16-fd1dedf2f5eb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-344-30	53217034430	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tizanidine	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-15	HUMAN PRESCRIPTION DRUG LABEL	1