Tizanidine

Product NDC
63629-8533
11-digit product format
636298533
Labeler code
63629
Product ID
63629-8533_ec9df1e6-a223-4854-9511-02933eda29a8
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
2 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412

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
63629-8533-1Tizanidine150 in 1 BOTTLETABLET150102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8533-1EA - Each63629-853366914f0d-0717-49f5-8c87-5a297bc2555c12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8533TIZANIDINE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_5f8a5b21-4adb-4f2c-91ae-bc33c3810752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN5f8a5b21-4adb-4f2c-91ae-bc33c3810752102
313412tizanidine 2 MG Oral TabletSCD5f8a5b21-4adb-4f2c-91ae-bc33c3810752102
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY5f8a5b21-4adb-4f2c-91ae-bc33c3810752102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8533-163629853301150 TABLET in 1 BOTTLE (63629-8533-1) 150 tablet2021-05-190000-00-00NoNoCurrent