tizanidine hydrochloride

Product NDC: 63629-6537
11-digit product format: 636296537
Labeler code: 63629
Product ID: 63629-6537_3ff8cd7c-7327-4b66-a9c0-38bf47e1a6e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076280
Marketing category: ANDA
Marketing start: 2002-06-27
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: 2021-12-31
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	63629-6537		D	Discontinued by firm	2026-08-03
excluded package	package	63629-6537	63629-6537-1	D	Discontinued by firm	2026-08-03
excluded package	package	63629-6537	63629-6537-2	D	Discontinued by firm	2026-08-03
excluded package	package	63629-6537	63629-6537-3	D	Discontinued by firm	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 1 · 52 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-6537-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-6537-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-6537-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-6537-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-6537-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-6537-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-6537-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-6537-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-6537-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-6537-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-6537-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-6537-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-6537-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-6537-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-6537-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-6537-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-6537-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-6537-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-6537-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-6537-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-6537-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-6537-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-6537-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-6537-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-6537-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-6537-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-6537-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-6537-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-6537-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-6537-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-6537-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-6537-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-6537-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-6537-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-6537-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-6537-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-6537-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-6537-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-6537-2	I	Inactivated by FDA	`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
A076280-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL			2002-11-26
A076280-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL			2002-06-27

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	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL		2002-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL		2002-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076280-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-11-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076280-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-06-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076280-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076280-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076280-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076280-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076280-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076280-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076280-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076280-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076280-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076280-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076280-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076280-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076280-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076280-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076280-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076280-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076280-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076280-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076280-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076280-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076280-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076280-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076280-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076280-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076280-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076280-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076280-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076280-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076280-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076280-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076280-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076280-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076280-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076280-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076280-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076280-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076280-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076280-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076280-002	AB	1	`3f0d92c62455…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-6537-1	2020-10-16	These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
63629-6537-2	2020-10-16	These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
63629-6537-3	2020-10-16	These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
63629-6537-1	2020-01-31	These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
63629-6537-2	2020-01-31	These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
63629-6537-3	2020-01-31	These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B53E3NMY5C	TIZANIDINE HYDROCHLORIDE	64461-82-1	TIZANIDINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6537-1	63629653701	60 TABLET in 1 BOTTLE (63629-6537-1)	60 tablet	2015-07-27	0000-00-00	No	No	Current
63629-6537-2	63629653702	30 TABLET in 1 BOTTLE (63629-6537-2)	30 tablet	2015-07-27	0000-00-00	No	No	Current
63629-6537-3	63629653703	90 TABLET in 1 BOTTLE (63629-6537-3)	90 tablet	2015-07-27	0000-00-00	No	No	Current