Tizanidne hydrochloride

Product NDC
63629-8872
11-digit product format
636298872
Labeler code
63629
Product ID
63629-8872_c91f6e6e-a154-4941-be7b-c54c5b0702a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212196
Marketing category
ANDA
Marketing start
2019-03-29
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
Tizanidne hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485485

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
63629-8872-1Tizanidne hydrochloride150 in 1 BOTTLECAPSULE150107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8872-1EA - Each63629-8872e197a4ae-d89d-45e2-b10b-5a370c7dced012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8872TIZANIDNE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20241207_00fcd792-18a4-45d9-9c6e-0634b54b152a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSN00fcd792-18a4-45d9-9c6e-0634b54b152a107
485485tizanidine 4 MG Oral CapsuleSCD00fcd792-18a4-45d9-9c6e-0634b54b152a107
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY00fcd792-18a4-45d9-9c6e-0634b54b152a107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8872-163629887201150 CAPSULE in 1 BOTTLE (63629-8872-1) 150 capsule2019-03-290000-00-00NoNoCurrent