Tizanidine

Product NDC: 72189-678
Requested package NDC: 72189-678-30
11-digit product format: 721890678
Labeler code: 72189
Product ID: 72189-678_5460dbf8-b30e-db94-e063-6394a90a5553
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA213798
Marketing category: ANDA
Marketing start: 2026-06-16
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: 2027-12-31
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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIZANIDINE HYDROCHLORIDE	6 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
485484	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
5460dbf8-b30d-db94-e063-6394a90a5553	Available on FDA.report

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 ndc (package): 72189-678-30 ndc (product): 72189-678 ndc11 (package): 72189067830
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
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
6AI06C00GW	TIZANIDINE	51322-75-9	Tizanidine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-678-30	72189067830	30 CAPSULE in 1 BOTTLE (72189-678-30)	30 capsule	2026-06-16	No	No	Current