Tizanidine

Product NDC: 52959-689
11-digit product format: 529590689
Labeler code: 52959
Product ID: 52959-689_efa8102d-2da1-4d92-b884-fd9c8bd80383
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA076286
Marketing category: ANDA
Marketing start: 2002-07-03
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: E
Listing certified through: 2018-12-31
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-689		I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-02	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-05	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-08	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-15	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-20	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-21	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-30	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-42	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-45	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-60	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-63	I	Inactivated by FDA	2026-08-03
excluded package	package	52959-689	52959-689-90	I	Inactivated by FDA	2026-08-03

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 5 · 286 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	52959-689-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-689-60	`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	52959-689-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-689-60	`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	52959-689-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-63	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-689-60	`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	52959-689-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-63	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-689-60	`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	52959-689-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-689-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-689-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-689-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-689-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-689-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-689-21	`cfe11265f3b6…`	`090c488252e2…`

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
A076286-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2002-07-03
A076286-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2002-07-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076286-001	AB
A076286-002	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	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`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	A076286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076286-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076286-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076286-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076286-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076286-002	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, Related label table
NDC	Related label
52959-689-02	Tizanidine Tablets USP
52959-689-05	Tizanidine Tablets USP
52959-689-08	Tizanidine Tablets USP
52959-689-15	Tizanidine Tablets USP
52959-689-20	Tizanidine Tablets USP
52959-689-21	Tizanidine Tablets USP
52959-689-30	Tizanidine Tablets USP
52959-689-42	Tizanidine Tablets USP
52959-689-45	Tizanidine Tablets USP
52959-689-60	Tizanidine Tablets USP
52959-689-63	Tizanidine Tablets USP
52959-689-90	Tizanidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-689-02	Tizanidine	120 in 1 BOTTLE	TABLET	120	3
52959-689-05	Tizanidine	150 in 1 BOTTLE	TABLET	150	3
52959-689-08	Tizanidine	180 in 1 BOTTLE	TABLET	180	3
52959-689-15	Tizanidine	15 in 1 BOTTLE	TABLET	15	3
52959-689-20	Tizanidine	20 in 1 BOTTLE	TABLET	20	3
52959-689-21	Tizanidine	21 in 1 BOTTLE	TABLET	21	3
52959-689-30	Tizanidine	30 in 1 BOTTLE	TABLET	30	3
52959-689-42	Tizanidine	42 in 1 BOTTLE	TABLET	42	3
52959-689-45	Tizanidine	45 in 1 BOTTLE	TABLET	45	3
52959-689-60	Tizanidine	60 in 1 BOTTLE	TABLET	60	3
52959-689-63	Tizanidine	63 in 1 BOTTLE	TABLET	63	3
52959-689-90	Tizanidine	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-689-02	EA - Each	52959-689	d929b0ec-e09d-4cdb-8efa-e91960d0cd5b	1	2012-07-24
52959-689-05	EA - Each	52959-689	1b9fb586-9d86-4948-b388-3472dfc99656	1	2012-07-24
52959-689-08	EA - Each	52959-689	c7f4608a-12eb-40a1-8008-e62a30bb88b3	1	2012-07-24
52959-689-15	EA - Each	52959-689	f1b352a4-69e9-4a7d-bb34-12221e0af130	1	2012-07-24
52959-689-20	EA - Each	52959-689	b48ca786-40da-4149-9119-fef921d05862	1	2012-07-24
52959-689-21	EA - Each	52959-689	12cab2ba-ea28-412e-9a48-b53c4536a499	1	2012-07-24
52959-689-30	EA - Each	52959-689	81d75dfd-e141-4dd7-850e-72bd1e83b72c	1	2012-07-24
52959-689-42	EA - Each	52959-689	1919fb4a-d8e4-4277-a27e-cd0603044e86	1	2012-07-24
52959-689-45	EA - Each	52959-689	f7df5488-90b1-45ce-8007-cd1817d9ec4a	1	2012-07-24
52959-689-60	EA - Each	52959-689	df80fa83-f853-4503-96d1-ef30e3466f4e	1	2012-07-24
52959-689-63	EA - Each	52959-689	15b32e41-f27c-4469-8fd0-5b24dae7f76a	1	2012-07-24
52959-689-90	EA - Each	52959-689	fcbafa4e-d1d6-4d6e-aceb-9cd4e3929a6f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Tizanidine Hydrochloride	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]	3
Tizanidine	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-689	TIZANIDINE TABLET [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 12 package rows	20111222_6d8e0262-5ccf-4447-90dd-f5eec069664c.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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	HAWAII REPACK, INC.	45de30ce-959f-4e2e-a974-6f90568139c9	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	59084f59-9a9b-49f0-a9f4-27f3eab9a228	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Redpharm Drug	54ade0c7-4bf0-54d4-e063-6294a90a8b17	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	St. Mary's Medical Park Pharmacy	c6b4486f-e847-64ee-e053-2995a90a855a	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	St. Mary's Medical Park Pharmacy	cfd52c0c-a7c2-e23d-e053-2a95a90abbd1	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	9bcc7f09-d2b5-4602-aaf3-5410b55ce275	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	7bbc81e5-ad3e-496b-908f-e6f500f6ad7e	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Direct_rx	29a275f9-de6b-ee63-e063-6294a90aba28	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	AvPAK	b694225c-1fa9-4726-89a6-fd3f87084248	2026-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	PD-Rx Pharmaceuticals, Inc.	ac897a5a-677b-4a6e-abb1-b810470200fc	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Northwind Health Company, LLC	da31fbeb-3781-5e75-e053-2a95a90adb73	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine HCl	TIZANIDINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	afc90292-c6bf-2d96-e053-2995a90abf00	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals Inc.	3c993e3c-ee52-45a7-be39-60eaac7a1092	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals, Inc.	32c3be66-5398-425c-ac65-e57ba819bb43	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Asclemed USA, Inc.	24d8b33f-d1fb-4b4a-afbe-e2e7134dce29	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	PHOENIX RX LLC	3a7b9b9a-9bf9-0b37-e063-6294a90a1c39	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	American Health Packaging	3670f9e3-988d-48e6-9df0-d403d699e08a	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	A-S Medication Solutions	180985f0-3fbd-4868-a826-b84101618a03	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	NuCare Pharmaceuticals,Inc.	fe2f5064-0b7c-d03d-e053-6294a90a9604	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Proficient Rx LP	c2353d09-3cb4-486e-8ae7-29339c1ba76b	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286

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	6d8e0262-5ccf-4447-90dd-f5eec069664c	3
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	6d8e0262-5ccf-4447-90dd-f5eec069664c	3
313412	tizanidine 2 MG Oral Tablet	SCD	6d8e0262-5ccf-4447-90dd-f5eec069664c	3
313413	tizanidine 4 MG Oral Tablet	SCD	6d8e0262-5ccf-4447-90dd-f5eec069664c	3
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	6d8e0262-5ccf-4447-90dd-f5eec069664c	3
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	6d8e0262-5ccf-4447-90dd-f5eec069664c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-689-02	52959068902	120 in 1 BOTTLE	Historical
52959-689-05	52959068905	150 in 1 BOTTLE	Historical
52959-689-08	52959068908	180 in 1 BOTTLE	Historical
52959-689-15	52959068915	15 in 1 BOTTLE	Historical
52959-689-20	52959068920	20 in 1 BOTTLE	Historical
52959-689-21	52959068921	21 in 1 BOTTLE	Historical
52959-689-30	52959068930	30 in 1 BOTTLE	Historical
52959-689-42	52959068942	42 in 1 BOTTLE	Historical
52959-689-45	52959068945	45 in 1 BOTTLE	Historical
52959-689-60	52959068960	60 in 1 BOTTLE	Historical
52959-689-63	52959068963	63 in 1 BOTTLE	Historical
52959-689-90	52959068990	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tizanidine Tablets USP	H.J. Harkins Company, Inc. \| Dr.Reddy's Laboratories Limited \| Dr.Reddy's Laboratories Limited FTO3	2011-12-21	HUMAN PRESCRIPTION DRUG LABEL	3