Tizanidine

Product NDC: 50436-6755
11-digit product format: 504366755
Labeler code: 50436
Product ID: 50436-6755_5ec52e0b-9ae4-41d0-9dda-fc2a28b8898e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA076286
Marketing category: ANDA
Marketing start: 2002-07-03
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
50436-6755-1	2020-01-31	C162847	48780-1	9d75b9d0-9b8f-f424-e053-dadaa90a57ce	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
50436-6755-2	2020-01-31	C162847	48780-1	9d75b9d0-9b8f-f424-e053-dadaa90a57ce	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
50436-6755-3	2020-01-31	C162847	48780-1	9d75b9d0-9b8f-f424-e053-dadaa90a57ce	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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-6755-1	Tizanidine	30 in 1 BOTTLE	TABLET	30	7
50436-6755-2	Tizanidine	60 in 1 BOTTLE	TABLET	60	7
50436-6755-3	Tizanidine	90 in 1 BOTTLE	TABLET	90	7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-6755	TIZANIDINE TABLET [UNIT DOSE SERVICES]	7	Legacy NDC, 3 package rows	20171207_988cbeae-64ed-4ce1-b503-f5e7b77f1a2a.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	988cbeae-64ed-4ce1-b503-f5e7b77f1a2a	7
313412	tizanidine 2 MG Oral Tablet	SCD	988cbeae-64ed-4ce1-b503-f5e7b77f1a2a	7
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	988cbeae-64ed-4ce1-b503-f5e7b77f1a2a	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-6755-1	50436675501	30 in 1 BOTTLE	Historical
50436-6755-2	50436675502	60 in 1 BOTTLE	Historical
50436-6755-3	50436675503	90 in 1 BOTTLE	Historical