Tizanidine HCL

Product NDC: 80425-0144
11-digit product format: 804250144
Labeler code: 80425
Product ID: 80425-0144_43cfb518-01fc-0ea4-e063-6394a90a06d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA212196
Marketing category: ANDA
Marketing start: 2019-03-29
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 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	Approval date
A212196-001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27
A212196-002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27
A212196-003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212196-001	AB
A212196-002	AB
A212196-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE / ORAL	AB	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-003	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	AB	2019-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212196-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE / ORAL	AB	2019-03-27	`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	A212196-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212196-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212196-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212196-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212196-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212196-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212196-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212196-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212196-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212196-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212196-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212196-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212196-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212196-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212196-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212196-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212196-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212196-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tizanidine HCL
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
c46c7aa3-69db-82dc-e053-2995a90ac251	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
80425-0144-1	Tizanidine HCL	30 in 1 BOTTLE	CAPSULE	30	9
80425-0144-2	Tizanidine HCL	60 in 1 BOTTLE	CAPSULE	60	9
80425-0144-3	Tizanidine HCL	90 in 1 BOTTLE	CAPSULE	90	9
80425-0144-4	Tizanidine HCL	120 in 1 BOTTLE	CAPSULE	120	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0144-1	EA - Each	80425-0144	b99d8b6e-963c-4879-8b61-3267b63e9b19	1	2023-06-06
80425-0144-2	EA - Each	80425-0144	2c88d83a-8c4b-4926-80b5-8419ee8e0ed4	1	2023-06-06
80425-0144-3	EA - Each	80425-0144	4ef89d59-832a-4d98-ae18-e74972a19a02	1	2023-06-06
80425-0144-4	EA - Each	80425-0144	35e993ff-b889-457e-a09e-a02fbef0a6ca	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0144	TIZANIDINE HCL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	8	Current NDC, Legacy NDC, 4 package rows	20250101_c46c7aa3-69db-82dc-e053-2995a90ac251.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	649f1f76-da33-4bdf-a38d-5ae3a9cb7987	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	70b1a815-8549-4602-af35-fdbedf5fad51	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	4fd5b1b8-ec86-42c2-9065-aee581f1bdd6	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	226b506f-6f85-48e8-b8e5-86442d74d951	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	31b40276-099b-482c-a13c-8fbbf1ebc50a	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	04febb37-00d6-4279-8c5f-171950278c8f	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	3288d98d-aa49-4a36-a6d9-703645d8bcd7	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3f569c5a-ec9d-4356-ac04-c17714ff68d1	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Ascend Laboratories, LLC	d7c97b79-da59-4e86-a01b-f91046d04f74	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Asclemed USA, Inc.	07b8db58-d037-477e-a62f-025e8a5afcb4	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidine HCL	TIZANIDINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	c46c7aa3-69db-82dc-e053-2995a90ac251	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196 ndc (product): 80425-0144
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	00fcd792-18a4-45d9-9c6e-0634b54b152a	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	a4233306-2954-496f-9686-22c48041710d	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Bryant Ranch Prepack	30df9966-5076-449f-867b-28cb9b835693	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196
Tizanidne hydrochloride	TIZANIDNE HYDROCHLORIDE	Asclemed USA, Inc.	1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c	2022-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212196 application number: ANDA212196

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	c46c7aa3-69db-82dc-e053-2995a90ac251	9
485485	tizanidine 4 MG Oral Capsule	SCD	c46c7aa3-69db-82dc-e053-2995a90ac251	9
485485	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Capsule	SY	c46c7aa3-69db-82dc-e053-2995a90ac251	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0144-1	80425014401	30 CAPSULE in 1 BOTTLE (80425-0144-1)	30 capsule	2019-03-29	0000-00-00	No	No	Current
80425-0144-2	80425014402	60 CAPSULE in 1 BOTTLE (80425-0144-2)	60 capsule	2019-03-29	0000-00-00	No	No	Current
80425-0144-3	80425014403	90 CAPSULE in 1 BOTTLE (80425-0144-3)	90 capsule	2019-03-29	0000-00-00	No	No	Current
80425-0144-4	80425014404	120 CAPSULE in 1 BOTTLE (80425-0144-4)	120 capsule	2025-11-17		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tizanidine HCL Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	9