Tizanidine

Product NDC
63629-2371
11-digit product format
636292371
Labeler code
63629
Product ID
63629-2371_2e2bd03e-7876-4c4e-8d08-c414d9a48dde
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
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 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
63629-2371-1Tizanidine1000 in 1 BOTTLETABLET1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2371-1EA - Each63629-23717ca3a723-4204-4072-8f26-ef840ffd814312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2371TIZANIDINE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240927_dd3bf952-50b1-4d50-9073-57fd6888053b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNdd3bf952-50b1-4d50-9073-57fd6888053b103
313413tizanidine 4 MG Oral TabletSCDdd3bf952-50b1-4d50-9073-57fd6888053b103
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYdd3bf952-50b1-4d50-9073-57fd6888053b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2371-1636292371011000 TABLET in 1 BOTTLE (63629-2371-1) 1000 tablet2021-02-180000-00-00NoNoCurrent