Tizanidine

Product NDC: 53217-344
11-digit product format: 532170344
Labeler code: 53217
Product ID: 53217-344_26758b13-8299-479f-996a-0ef4dbe0bd9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA091283
Marketing category: ANDA
Marketing start: 2017-11-28
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-344-30	2020-01-31	C162847	48780-1	9d75b9d0-8f35-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-344-30	Tizanidine	30 in 1 BOTTLE, PLASTIC	TABLET	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-344	TIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180815_a3b676eb-c097-46f5-ba16-fd1dedf2f5eb.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313412	tiZANidine HCl 2 MG Oral Tablet	PSN	a3b676eb-c097-46f5-ba16-fd1dedf2f5eb	1
313412	tizanidine 2 MG Oral Tablet	SCD	a3b676eb-c097-46f5-ba16-fd1dedf2f5eb	1
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	a3b676eb-c097-46f5-ba16-fd1dedf2f5eb	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-344-30	53217034430	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tizanidine	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-15	HUMAN PRESCRIPTION DRUG LABEL	1