Tizanidine

Product NDC: 70518-0133
11-digit product format: 705180133
Labeler code: 70518
Product ID: 70518-0133_54ee83fa-c093-c6e0-e063-6294a90a4d25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076286
Marketing category: ANDA
Marketing start: 2017-01-07
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-0133	70518-0133-2	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	70518-0133-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-0133-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-0133-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	70518-0133-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	70518-0133-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	70518-0133-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	70518-0133-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	70518-0133-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	70518-0133-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	70518-0133-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	70518-0133-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	70518-0133-3	`367a005e9d99…`	`383a685ebd0f…`

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

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 · 86 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
2026-09-14 22:38:34	2026-08	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076286-001	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2002-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076286-002	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2002-07-03	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A076286-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076286-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076286-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076286-002	AB	1	`caaa826d4ba7…`
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…`

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	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
59084f59-9a9b-49f0-a9f4-27f3eab9a228	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
70518-0133-0	Tizanidine	60 in 1 BOTTLE	TABLET	60	20
70518-0133-1	Tizanidine	90 in 1 BOTTLE, PLASTIC	TABLET	90	20
70518-0133-2	Tizanidine	15 in 1 BOTTLE, PLASTIC	TABLET	15	20
70518-0133-3	Tizanidine	30 in 1 BOTTLE, PLASTIC	TABLET	30	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-0133-0	EA - Each	70518-0133	1e70cbef-8da1-45cf-a8a6-d7107648b445	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0133	TIZANIDINE TABLET [REMEDYREPACK INC.]	14	Current NDC, Legacy NDC, 4 package rows	20250529_59084f59-9a9b-49f0-a9f4-27f3eab9a228.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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Tizanidine	TIZANIDINE	NorthStar Rx LLC	eed74219-9d4a-fecd-1bb9-ad6c01ad3e9d	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	NuCare Pharmaceuticals,Inc.	a7470959-8943-215b-e053-2a95a90a7878	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine Hydrochloride	TIZANIDINE HYDROCHLORIDE	Quality Care Products LLC	87f8a776-e8ae-4aed-a221-98ca72a2bedf	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Quality Care Products, LLC	b68a9f81-7138-48cf-b987-b8d284e8105a	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Dr. Reddy's Laboratories Limited	a42f3479-f2c2-8214-d547-c5cae9bfed1e	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Asclemed USA, Inc.	81385ce2-1d82-4987-8e18-83c823e10b99	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	492c99bd-2cd0-43be-bd70-800b739b7e83	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	A-S Medication Solutions	67b2af93-92c9-4c33-8fa0-548bfcc9c538	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	A-S Medication Solutions	247ae1f4-6ec8-4e34-aae4-13495d8f64e5	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	b254a0f4-efb1-4874-ae45-1dc5fe316964	2021-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076286 application number: ANDA076286
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	82084f4e-00d0-c298-c13a-88a6c0860b02	2021-12-08	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	59084f59-9a9b-49f0-a9f4-27f3eab9a228	20
313413	tizanidine 4 MG Oral Tablet	SCD	59084f59-9a9b-49f0-a9f4-27f3eab9a228	20
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	59084f59-9a9b-49f0-a9f4-27f3eab9a228	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0133-0	70518013300	60 TABLET in 1 BOTTLE (70518-0133-0)	60 tablet	2017-01-07	0000-00-00	No	No	Current
70518-0133-1	70518013301	90 TABLET in 1 BOTTLE, PLASTIC (70518-0133-1)	90 tablet	2017-04-05	0000-00-00	No	No	Current
70518-0133-2	70518013302	15 TABLET in 1 BOTTLE, PLASTIC (70518-0133-2)	15 tablet	2017-08-30	0000-00-00	No	No	Current
70518-0133-3	70518013303	30 TABLET in 1 BOTTLE, PLASTIC (70518-0133-3)	30 tablet	2021-01-07	0000-00-00	No	No	Current