Zanaflex

Product NDC: 10144-604
11-digit product format: 101440604
Labeler code: 10144
Product ID: 10144-604_7897aa33-13b7-f553-e053-2a91aa0a2c3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Acorda Therapeutics, Inc.
Application: NDA021447
Marketing category: NDA
Marketing start: 2005-04-04
Marketing end: 2019-07-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10144-604		D	Discontinued by firm		2026-08-17
excluded package	package	10144-604	10144-604-15	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 · 24 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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`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	10144-604-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10144-604-15	EA - Each	10144-604	c05501bc-a265-4d95-b401-9220a0dc19d6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
tizanidine hydrochloride	ACTIVE INGREDIENT	B53E3NMY5C	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
tizanidine	ACTIVE MOIETY	6AI06C00GW	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
gelatin	INACTIVE INGREDIENT	2G86QN327L	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [ACORDA THERAPEUTICS, INC.]	11
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
tizanidine hydrochloride	ACTIVE INGREDIENT	B53E3NMY5C	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
tizanidine	ACTIVE MOIETY	6AI06C00GW	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
HYDROXYMETHYL CELLULOSE	INACTIVE INGREDIENT	273FM27VK1	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485485	tiZANidine HCl 4 MG Oral Capsule	PSN	939d9fec-727e-488e-adc4-cc941292b23e	1
485485	tiZANidine HCl 4 MG Oral Capsule	PSN	b581d63f-61cb-41b6-a7ca-24bd0b32a8ae	1
485484	tiZANidine HCl 6 MG Oral Capsule	PSN	939d9fec-727e-488e-adc4-cc941292b23e	1
583211	Zanaflex 4 MG Oral Capsule	PSN	b581d63f-61cb-41b6-a7ca-24bd0b32a8ae	1
583211	Zanaflex 4 MG Oral Capsule	PSN	939d9fec-727e-488e-adc4-cc941292b23e	1
580267	Zanaflex 6 MG Oral Capsule	PSN	939d9fec-727e-488e-adc4-cc941292b23e	1
583211	tizanidine 4 MG Oral Capsule [Zanaflex]	SBD	939d9fec-727e-488e-adc4-cc941292b23e	1
583211	tizanidine 4 MG Oral Capsule [Zanaflex]	SBD	b581d63f-61cb-41b6-a7ca-24bd0b32a8ae	1
580267	tizanidine 6 MG Oral Capsule [Zanaflex]	SBD	939d9fec-727e-488e-adc4-cc941292b23e	1
485485	tizanidine 4 MG Oral Capsule	SCD	939d9fec-727e-488e-adc4-cc941292b23e	1
485485	tizanidine 4 MG Oral Capsule	SCD	b581d63f-61cb-41b6-a7ca-24bd0b32a8ae	1
485484	tizanidine 6 MG Oral Capsule	SCD	939d9fec-727e-488e-adc4-cc941292b23e	1
485485	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Capsule	SY	939d9fec-727e-488e-adc4-cc941292b23e	1
485485	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Capsule	SY	b581d63f-61cb-41b6-a7ca-24bd0b32a8ae	1
485484	tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral Capsule	SY	939d9fec-727e-488e-adc4-cc941292b23e	1
583211	Zanaflex 4 MG (tizanidine hydrochloride 4.58 MG) Oral Capsule	SY	939d9fec-727e-488e-adc4-cc941292b23e	1
583211	Zanaflex 4 MG (tizanidine hydrochloride 4.58 MG) Oral Capsule	SY	b581d63f-61cb-41b6-a7ca-24bd0b32a8ae	1
583211	Zanaflex 4 MG Oral Capsule	SY	b581d63f-61cb-41b6-a7ca-24bd0b32a8ae	1
583211	Zanaflex 4 MG Oral Capsule	SY	939d9fec-727e-488e-adc4-cc941292b23e	1
580267	Zanaflex 6 MG (tizanidine hydrochloride 6.87 MG) Oral Capsule	SY	939d9fec-727e-488e-adc4-cc941292b23e	1
580267	Zanaflex 6 MG Oral Capsule	SY	939d9fec-727e-488e-adc4-cc941292b23e	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zanaflex	Acorda Therapeutics, Inc. \| ALKERMES GAINESVILLE LLC \| Sharp Corporation \| PATHEON INC. \| ALKERMES PHARMA IRELAND LIMTED	2018-10-19	HUMAN PRESCRIPTION DRUG LABEL	13
ZANAFLEX - STAT RX USA LLC	STAT RX USA LLC	2011-04-25	HUMAN PRESCRIPTION DRUG LABEL	1
Zanaflex Capsules ® Zanaflex Tablets ®	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1