Tizanidine hydrochloride

Product NDC
71209-066
11-digit product format
712090066
Labeler code
71209
Product ID
71209-066_6edcd49b-7ddf-4ca2-9946-6f1ff6bf22e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA210021
Marketing category
ANDA
Marketing start
2017-12-29
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
6 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485484, 485485, 485486

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
71209-066-07Tizanidine hydrochloride150 in 1 BOTTLECAPSULE1508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-066TIZANIDINE HYDROCHLORIDE CAPSULE [CADILA PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 1 package rows20241228_f2f4e117-0318-4bbd-aaa7-fab803714f21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSNf2f4e117-0318-4bbd-aaa7-fab803714f218
485485tiZANidine HCl 4 MG Oral CapsulePSNf2f4e117-0318-4bbd-aaa7-fab803714f218
485484tiZANidine HCl 6 MG Oral CapsulePSNf2f4e117-0318-4bbd-aaa7-fab803714f218
485486tizanidine 2 MG Oral CapsuleSCDf2f4e117-0318-4bbd-aaa7-fab803714f218
485485tizanidine 4 MG Oral CapsuleSCDf2f4e117-0318-4bbd-aaa7-fab803714f218
485484tizanidine 6 MG Oral CapsuleSCDf2f4e117-0318-4bbd-aaa7-fab803714f218
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSYf2f4e117-0318-4bbd-aaa7-fab803714f218
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYf2f4e117-0318-4bbd-aaa7-fab803714f218
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYf2f4e117-0318-4bbd-aaa7-fab803714f218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-066-0771209006607150 CAPSULE in 1 BOTTLE (71209-066-07) 150 capsule2017-12-290000-00-00NoNoCurrent