Tizanidine

Product NDC: 51655-603
Requested package NDC: 51655-603-54
11-digit product format: 516550603
Labeler code: 51655
Product ID: 51655-603_4a65db4c-b8f9-9bba-e063-6394a90aa8bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA076286
Marketing category: ANDA
Marketing start: 2021-02-19
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: 2027-12-31
Current FDA listing: Yes

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
A076286-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2002-07-03
A076286-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2002-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076286-001	AB
A076286-002	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 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	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076286-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076286-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076286-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076286-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076286-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tizanidine
Listing expiration: 2027-12-31

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
313413	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
da31fbeb-3781-5e75-e053-2a95a90adb73	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51655-603-20	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
51655-603-26	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
51655-603-52	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
51655-603-54	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51655-603-20	Tizanidine	20 in 1 BOTTLE, PLASTIC	TABLET	20	3
51655-603-26	Tizanidine	90 in 1 BOTTLE, PLASTIC	TABLET	90	3
51655-603-52	Tizanidine	30 in 1 BOTTLE, PLASTIC	TABLET	30	3
51655-603-54	Tizanidine	15 in 1 BOTTLE, PLASTIC	TABLET	15	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-603	TIZANIDINE TABLET [NORTHWIND PHARMACEUTICALS]	1	Current NDC, 4 package rows	20230320_da31fbeb-3781-5e75-e053-2a95a90adb73.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	HAWAII REPACK, INC.	45de30ce-959f-4e2e-a974-6f90568139c9	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	59084f59-9a9b-49f0-a9f4-27f3eab9a228	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Redpharm Drug	54ade0c7-4bf0-54d4-e063-6294a90a8b17	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	St. Mary's Medical Park Pharmacy	c6b4486f-e847-64ee-e053-2995a90a855a	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	St. Mary's Medical Park Pharmacy	cfd52c0c-a7c2-e23d-e053-2a95a90abbd1	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	9bcc7f09-d2b5-4602-aaf3-5410b55ce275	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	REMEDYREPACK INC.	7bbc81e5-ad3e-496b-908f-e6f500f6ad7e	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Direct_rx	29a275f9-de6b-ee63-e063-6294a90aba28	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	AvPAK	b694225c-1fa9-4726-89a6-fd3f87084248	2026-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	PD-Rx Pharmaceuticals, Inc.	ac897a5a-677b-4a6e-abb1-b810470200fc	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Northwind Health Company, LLC	da31fbeb-3781-5e75-e053-2a95a90adb73	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286 ndc (package): 51655-603-54 ndc (product): 51655-603 ndc11 (package): 51655060354
Tizanidine HCl	TIZANIDINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	afc90292-c6bf-2d96-e053-2995a90abf00	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals Inc.	3c993e3c-ee52-45a7-be39-60eaac7a1092	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Preferred Pharmaceuticals, Inc.	32c3be66-5398-425c-ac65-e57ba819bb43	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Asclemed USA, Inc.	24d8b33f-d1fb-4b4a-afbe-e2e7134dce29	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	PHOENIX RX LLC	3a7b9b9a-9bf9-0b37-e063-6294a90a1c39	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	American Health Packaging	3670f9e3-988d-48e6-9df0-d403d699e08a	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	A-S Medication Solutions	180985f0-3fbd-4868-a826-b84101618a03	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	NuCare Pharmaceuticals,Inc.	fe2f5064-0b7c-d03d-e053-6294a90a9604	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Proficient Rx LP	c2353d09-3cb4-486e-8ae7-29339c1ba76b	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	da31fbeb-3781-5e75-e053-2a95a90adb73	3
313413	tizanidine 4 MG Oral Tablet	SCD	da31fbeb-3781-5e75-e053-2a95a90adb73	3
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	da31fbeb-3781-5e75-e053-2a95a90adb73	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-603-54	51655060354	15 TABLET in 1 BOTTLE, PLASTIC (51655-603-54)	15 tablet	2021-07-19	No	No	Current