Tizanidine

Product NDC
71335-3016
11-digit product format
713353016
Labeler code
71335
Product ID
71335-3016_f722dde4-55ee-44f4-9d1a-07214c62cd83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313413

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0ff02d8-b711-423c-b7d1-ada00d81c743Product name120250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01Product name820250313
b404127e-1c01-47bb-874e-db1e0b6bd9afProduct name420250313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3016-1Tizanidine90 in 1 BOTTLETABLET901
71335-3016-2Tizanidine15 in 1 BOTTLETABLET151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNfefe8332-32eb-4b81-978f-b23b334d7d571
313413tizanidine 4 MG Oral TabletSCDfefe8332-32eb-4b81-978f-b23b334d7d571
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYfefe8332-32eb-4b81-978f-b23b334d7d571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3016-17133530160190 TABLET in 1 BOTTLE (71335-3016-1) 90 tablet2026-02-04NoNoHistorical
71335-3016-27133530160215 TABLET in 1 BOTTLE (71335-3016-2) 15 tablet2026-02-04NoNoHistorical