tizanidine hydrochloride

Product NDC: 80425-0474
Requested package NDC: 80425-0474-2
11-digit product format: 804250474
Labeler code: 80425
Product ID: 80425-0474_43cfd33c-ce85-2381-e063-6394a90a4f1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA213798
Marketing category: ANDA
Marketing start: 2025-01-20
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213798-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27
A213798-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27
A213798-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27
A213798-004	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213798-001	AB
A213798-002	AB
A213798-003	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 · 122 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
2026-09-14 22:38:34	2026-08	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213798-004	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213798-004	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-004	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-004	TIZANIDINE HYDROCHLORIDE	EQ 8MG BASE	CAPSULE / ORAL		RS	2025-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213798-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB		2020-05-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213798-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213798-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213798-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213798-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213798-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213798-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213798-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213798-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213798-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213798-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213798-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213798-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213798-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213798-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213798-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213798-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213798-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213798-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: tizanidine hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIZANIDINE HYDROCHLORIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B53E3NMY5C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485485	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2c2bdad9-74a5-8508-e063-6294a90aac7f	Available on FDA.report

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0474-1	tizanidine hydrochloride	30 in 1 BOTTLE	CAPSULE	30	2
80425-0474-2	tizanidine hydrochloride	60 in 1 BOTTLE	CAPSULE	60	2
80425-0474-3	tizanidine hydrochloride	90 in 1 BOTTLE	CAPSULE	90	2
80425-0474-4	tizanidine hydrochloride	120 in 1 BOTTLE	CAPSULE	120	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0474-1	EA - Each	80425-0474	a2f00589-24a0-4f4d-91df-eee4f5306ec9	1	2025-03-04
80425-0474-2	EA - Each	80425-0474	1e80861c-19d6-4fb9-881d-95edf73a63ae	1	2025-03-04
80425-0474-3	EA - Each	80425-0474	0b293242-db21-416b-a853-1fb8dda34ead	1	2025-03-04
80425-0474-4	EA - Each	80425-0474	32fa12f9-6e3c-483f-9d73-f6cec695a9a6	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0474	TIZANIDINE HYDROCHLORIDE CAPSULE [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 4 package rows	20250122_2c2bdad9-74a5-8508-e063-6294a90aac7f.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	Direct_Rx	5460dbf8-b30d-db94-e063-6394a90a5553	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Trifluent Pharma, LLC	4a2cf456-58c5-c26d-e063-6294a90a0b24	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ebccdb33-2b3c-4071-9765-8d95bcbc9b5f	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2c2bdad9-74a5-8508-e063-6294a90aac7f	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798 ndc (package): 80425-0474-2 ndc (product): 80425-0474 ndc11 (package): 80425047402
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Bryant Ranch Prepack	9d127a0b-b182-4c8a-91a3-311cc936fd4c	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
Zanaflex	TIZANIDINE HYDROCHLORIDE	Trifluent Pharma, LLC	9833a1b8-f530-4a06-bc77-7d11b6e94c65	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Advagen Pharma Limited	7f39499a-98cf-4d13-9b07-ccb5c22e43c8	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798
tizanidine hydrochloride	TIZANIDINE HYDROCHLORIDE	Bryant Ranch Prepack	58c10b87-004e-4d2d-b5c1-b353c2cd071f	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213798 application number: ANDA213798

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	2c2bdad9-74a5-8508-e063-6294a90aac7f	2
485485	tizanidine 4 MG Oral Capsule	SCD	2c2bdad9-74a5-8508-e063-6294a90aac7f	2
485485	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Capsule	SY	2c2bdad9-74a5-8508-e063-6294a90aac7f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0474-2	80425047402	60 CAPSULE in 1 BOTTLE (80425-0474-2)	60 capsule	2025-01-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tizanidine hydrochloride	Advanced Rx of Tennessee, LLC	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	2