16714-172 NDC - TIZANIDINE

Drug Information

Product NDC: 16714-172
Proprietary Name: Tizanidine
Non Proprietary Name: Tizanidine
Active Ingredient(s): 4 mg/1 TIZANIDINE HYDROCHLORIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Adrenergic alpha2-Agonists [MoA]; Central alpha-2 Adrenergic Agonist [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	NorthStar Rx LLC
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA076286
Marketing Category:	ANDA
Start Marketing Date:	6/15/2021

Package Information

No.	Package Code	Package Description	Billing Unit
1	16714-172-01	150 TABLET in 1 BOTTLE (16714-172-01)	EA
2	16714-172-02	1000 TABLET in 1 BOTTLE (16714-172-02)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	16714-172	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Tizanidine	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Tizanidine	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	6/15/2021	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
APPLICATION NUMBER	ANDA076286	The translation of the dosage form Code submitted by the firm.
LABELER NAME	NorthStar Rx LLC	The translation of the route code submitted by the firm, indicating route of administration.
SUBSTANCE NAME	TIZANIDINE HYDROCHLORIDE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	4
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]

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This page was last updated on: 12/6/2025

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