tizanidine hydrochloride

Product NDC: 63629-5139
Requested package NDC: 63629-5139-5
11-digit product format: 636295139
Labeler code: 63629
Product ID: 63629-5139_b703f118-c09d-41a3-b256-d2edd16350c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine hydrochloride
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA021447
Marketing category: NDA
Marketing start: 2012-02-06
Marketing end: 0000-00-00
Substance: TIZANIDINE HYDROCHLORIDE
Active strength: 6 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-5139	63629-5139-5	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-5139	63629-5139-5	I	Inactivated by FDA		excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-5139	63629-5139-5	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021447-001	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29
N021447-002	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29
N021447-003	ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021447-001	AB
N021447-002	AB
N021447-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-002	ZANAFLEX	EQ 4MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-003	ZANAFLEX	EQ 6MG BASE	CAPSULE / ORAL	AB	RLD, RS	2002-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021447-001	ZANAFLEX	EQ 2MG BASE	CAPSULE / ORAL	AB	RLD	2002-08-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N021447-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021447-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021447-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021447-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021447-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021447-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021447-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021447-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021447-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021447-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021447-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021447-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021447-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021447-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021447-001	AB	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-5139-1	2024-05-17	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-2	2024-05-17	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-3	2024-05-17	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-4	2024-05-17	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-5	2024-05-17	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-1	2024-01-30	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-2	2024-01-30	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-3	2024-01-30	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-4	2024-01-30	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-5	2024-01-30	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-1	2022-02-16	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-2	2022-02-16	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-3	2022-02-16	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-1	2019-11-27	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-2	2019-11-27	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002
63629-5139-3	2019-11-27	These highlights do not include all the information needed to use tizanidine hydrochloride capsules safely and effectively. See full prescribing information for tizanidine hydrochloride capsules . TIZANIDINE hydrochloride capsules, for oral use Initial U.S. Approval: 2002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000
SUCROSE	INACTIVE INGREDIENT	C151H8M554	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-5139	TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK]	1002	Legacy NDC	20240518_b703f118-c09d-41a3-b256-d2edd16350c8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zanaflex	TIZANIDINE HYDROCHLORIDE	Legacy Pharma USA, Inc.	60c27d35-7349-4fc6-86ad-70fffdbe3e08	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021447 application number: NDA021447
Zanaflex	TIZANIDINE HYDROCHLORIDE	Covis Pharma US, Inc	043d9e51-bfa2-4add-9058-5ece332f7e99	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021447 application number: NDA021447
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Actavis Pharma, Inc.	cb8b01b3-bcec-4762-9d67-0db018ef6b22	2023-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021447 application number: NDA021447

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	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-5139-5	63629513905	28 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-5139-5)	2022-02-15	0000-00-00	No	No	Current