Tizanidine

Product NDC: 71610-345
11-digit product format: 716100345
Labeler code: 71610
Product ID: 71610-345_3bf538d4-6ba2-4d28-a7a7-02dc45819d30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076416
Marketing category: ANDA
Marketing start: 2015-07-28
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: 2020-12-31
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
71610-345-09	2023-01-30	C162847	48780-1	f386c649-f72b-0266-e053-dadaa90a7c1a	Tizanidine Tablets, USP Rx Only These highlights do not include all the information needed to use Tizanidine Tablets, USP safely and effectively. See full prescribing information for Tizanidine Tablets, USP. Tizanidine Tablets, USP (tizanidine hydrochloride) tablets, for oral use Initial U.S. Approval: 1996

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-345-09	Tizanidine	9000 in 1 BOTTLE	TABLET	9000		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-345	TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20191017_df8afbf5-c83a-4149-a63c-5e8245055204.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	df8afbf5-c83a-4149-a63c-5e8245055204	1
313412	tizanidine 2 MG Oral Tablet	SCD	df8afbf5-c83a-4149-a63c-5e8245055204	1
313412	tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet	SY	df8afbf5-c83a-4149-a63c-5e8245055204	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-345-09	71610034509	9000 TABLET in 1 BOTTLE (71610-345-09)	9000 tablet	2019-09-23	0000-00-00	No	No	Current