tizanidine

Product NDC: 60505-0251
11-digit product format: 605050251
Labeler code: 60505
Product ID: 60505-0251_95820c11-e6e2-4f26-6af9-2cc60ef94c41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA076533
Marketing category: ANDA
Marketing start: 2004-01-16
Substance: TIZANIDINE HYDROCHLORIDE
Active strength: 2 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 42.

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
A076533-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2004-01-16
A076533-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2004-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076533-001	AB
A076533-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076533-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2004-01-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076533-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2004-01-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A076533-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076533-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076533-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076533-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076533-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076533-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076533-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076533-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076533-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076533-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076533-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076533-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076533-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076533-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076533-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076533-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076533-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076533-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076533-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076533-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076533-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076533-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076533-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076533-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076533-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076533-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076533-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076533-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076533-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIZANIDINE HYDROCHLORIDE	2 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313412	Internal RxNorm lookup
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
01c0d3d3-2373-a1b7-822a-80a66291a248	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0251-1	tizanidine	100 in 1 BOTTLE	TABLET	100	14
60505-0251-2	tizanidine	1000 in 1 BOTTLE	TABLET	1000	14
60505-0251-3	tizanidine	150 in 1 BOTTLE	TABLET	150	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0251-2	EA - Each	60505-0251	e0f3dc20-593d-4ac7-83b4-6c6f7d93a523	1	2012-07-24
60505-0251-3	EA - Each	60505-0251	d976963b-4a04-441d-95c7-b88875d1601d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tizanidine Hydrochloride	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [APOTEX CORP.]	5
Tizanidine	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [APOTEX CORP.]	5
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [APOTEX CORP.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [APOTEX CORP.]	5
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [APOTEX CORP.]	5
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [APOTEX CORP.]	5
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	4
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	4
Tizanidine Hydrochloride	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [DIRECT RX]	2
Tizanidine	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [DIRECT RX]	2
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [DIRECT RX]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [DIRECT RX]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
TIZANIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1
tizanidine hydrochloride	ACTIVE INGREDIENT	B53E3NMY5C	TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
Tizanidine	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0251	TIZANIDINE TABLET [APOTEX CORP.]	14	Current NDC, Legacy NDC, 3 package rows	20250313_01c0d3d3-2373-a1b7-822a-80a66291a248.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tizanidine	TIZANIDINE	Major Pharmaceuticals	d24e0cda-a22f-404f-b861-f85090cef099	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Preferred Pharmaceuticals Inc.	f0e4eb26-6733-4df6-bb3c-86bf4d976f42	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Cardinal Health 107, LLC	eeb18068-75c8-42d0-a006-1b134648333f	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Apotex Corp.	01c0d3d3-2373-a1b7-822a-80a66291a248	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533 ndc (product): 60505-0251
tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Proficient Rx LP	cf77e63c-a62a-43fc-8705-0558925e04e8	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533
tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	d3b8d863-d13d-467c-97bf-5db9708036db	2020-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076533 application number: ANDA076533

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
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	01c0d3d3-2373-a1b7-822a-80a66291a248	14
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	01c0d3d3-2373-a1b7-822a-80a66291a248	14
313412	tizanidine 2 MG Oral Tablet	SCD	01c0d3d3-2373-a1b7-822a-80a66291a248	14
313413	tizanidine 4 MG Oral Tablet	SCD	01c0d3d3-2373-a1b7-822a-80a66291a248	14
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	01c0d3d3-2373-a1b7-822a-80a66291a248	14
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	01c0d3d3-2373-a1b7-822a-80a66291a248	14
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	95c5c9b1-43fe-488d-898b-76663f14768a	4
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	10457e1d-068f-7071-e054-00144ff8d46c	4
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	95c5c9b1-43fe-488d-898b-76663f14768a	4
313412	tizanidine 2 MG Oral Tablet	SCD	10457e1d-068f-7071-e054-00144ff8d46c	4
313412	tizanidine 2 MG Oral Tablet	SCD	95c5c9b1-43fe-488d-898b-76663f14768a	4
313413	tizanidine 4 MG Oral Tablet	SCD	95c5c9b1-43fe-488d-898b-76663f14768a	4
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	10457e1d-068f-7071-e054-00144ff8d46c	4
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	95c5c9b1-43fe-488d-898b-76663f14768a	4
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	95c5c9b1-43fe-488d-898b-76663f14768a	4
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	54bd58ee-76f6-44e7-83bb-fe752c3cbf9a	2
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	54bd58ee-76f6-44e7-83bb-fe752c3cbf9a	2
313412	tizanidine 2 MG Oral Tablet	SCD	54bd58ee-76f6-44e7-83bb-fe752c3cbf9a	2
313413	tizanidine 4 MG Oral Tablet	SCD	54bd58ee-76f6-44e7-83bb-fe752c3cbf9a	2
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	54bd58ee-76f6-44e7-83bb-fe752c3cbf9a	2
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	54bd58ee-76f6-44e7-83bb-fe752c3cbf9a	2
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	1fe204a5-8ca8-1fa1-e054-00144ff8d46c	1
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	d3b8d863-d13d-467c-97bf-5db9708036db	1
313412	tizanidine 2 MG Oral Tablet	SCD	1fe204a5-8ca8-1fa1-e054-00144ff8d46c	1
313412	tizanidine 2 MG Oral Tablet	SCD	d3b8d863-d13d-467c-97bf-5db9708036db	1
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	1fe204a5-8ca8-1fa1-e054-00144ff8d46c	1
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	d3b8d863-d13d-467c-97bf-5db9708036db	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0251-1	60505025101	100 TABLET in 1 BOTTLE (60505-0251-1)	100 tablet	2004-01-16	0000-00-00	No	No	Current
60505-0251-2	60505025102	1000 TABLET in 1 BOTTLE (60505-0251-2)	1000 tablet	2004-01-16	0000-00-00	No	No	Current
60505-0251-3	60505025103	150 TABLET in 1 BOTTLE (60505-0251-3)	150 tablet	2004-01-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tizanidine	Apotex Corp. \| Apotex Inc.	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	14
tizanidine	A-S Medication Solutions	2023-04-03	HUMAN PRESCRIPTION DRUG LABEL	16
tizanidine	St. Mary's Medical Park Pharmacy \| Apotex Inc.	2021-12-06	HUMAN PRESCRIPTION DRUG LABEL	5
tizanidine	Preferred Pharmaceuticals, Inc.	2021-09-21	HUMAN PRESCRIPTION DRUG LABEL	7
tizanidine	NuCare Pharmaceuticals, Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	2
tizanidine	Golden State Medical Supply, Inc.	2021-02-04	HUMAN PRESCRIPTION DRUG LABEL	5
tizanidine	Aphena Pharma Solutions - Tennessee, LLC	2020-08-28	HUMAN PRESCRIPTION DRUG LABEL	1
tizanidine	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	5
tizanidine	Unit Dose Services	2017-12-13	HUMAN PRESCRIPTION DRUG LABEL	4
TIZANIDINE	Direct Rx	2015-11-05	HUMAN PRESCRIPTION DRUG LABEL	2
tizanidine	Blenheim Pharmacal, Inc.	2015-09-16	HUMAN PRESCRIPTION DRUG LABEL	1
tizanidine	Blenheim Pharmacal, Inc.	2015-04-23	HUMAN PRESCRIPTION DRUG LABEL	4