Tizanidine

Product NDC: 58517-380
11-digit product format: 585170380
Labeler code: 58517
Product ID: 58517-380_4ed0bea5-7cc0-4c59-9517-6628c53a27b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tizanidine
Dosage form: TABLET
Route: ORAL
Labeler: New Horizon Rx Group, LLC
Application: ANDA076416
Marketing category: ANDA
Marketing start: 2013-08-25
Marketing end: 0000-00-00
Substance: TIZANIDINE
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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
58517-380-30	2020-01-31	C162847	48780-1	9d75b9d0-1da7-f424-e053-dadaa90a57ce	Tizanidine Tablets, USP Rx only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58517-380-30	Tizanidine	30 in 1 BOTTLE	TABLET	30		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58517-380-30	EA - Each	58517-380	231c73c1-288b-4b98-87b0-de2b8a1af0e1	1	2013-11-04

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIZANIDINE	ACTIVE INGREDIENT	6AI06C00GW	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3
TIZANIDINE	ACTIVE MOIETY	6AI06C00GW	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58517-380	TIZANIDINE TABLET [NEW HORIZON RX GROUP, LLC]	3	Legacy NDC, 1 package rows	20131228_d0182933-afae-4db4-9aa1-a869dcf39658.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6AI06C00GW	TIZANIDINE	51322-75-9	TIZANIDINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313413	tiZANidine HCl 4 MG Oral Tablet	PSN	d0182933-afae-4db4-9aa1-a869dcf39658	3
313413	tizanidine 4 MG Oral Tablet	SCD	d0182933-afae-4db4-9aa1-a869dcf39658	3
313413	tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet	SY	d0182933-afae-4db4-9aa1-a869dcf39658	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58517-380-30	58517038030	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tizanidine Tablets, USP Rx only	New Horizon Rx Group, LLC \| CARACO PHARMACEUTICAL LABORATORIES, LTD.	2013-12-27	HUMAN PRESCRIPTION DRUG LABEL	3