FDA.reportPublic FDA data

Tizanidne hydrochloride

Product NDC
67877-611
11-digit product format
678770611
Labeler code
67877
Product ID
67877-611_628c23e5-c9ed-453b-a83e-1514d6b02912
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
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
67877-611-05Tizanidne hydrochloride500 in 1 BOTTLECAPSULE5008
67877-611-15Tizanidne hydrochloride150 in 1 BOTTLECAPSULE1508
67877-611-33Tizanidne hydrochloride1 in 1 CARTONCAPSULE18
67877-611-33Tizanidne hydrochloride10 in 1 BLISTER PACKCAPSULE108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-611-15EA - Each67877-6119fe8b4a3-e789-4aff-8688-8097945233a812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-611TIZANIDNE HYDROCHLORIDE CAPSULE [ASCEND LABORATORIES, LLC]6Current NDC, Legacy NDC, 4 package rows20221029_d7c97b79-da59-4e86-a01b-f91046d04f74.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
485485tiZANidine HCl 4 MG Oral CapsulePSN70b1a815-8549-4602-af35-fdbedf5fad51101
485485tiZANidine HCl 4 MG Oral CapsulePSN04febb37-00d6-4279-8c5f-171950278c8f101
485485tizanidine 4 MG Oral CapsuleSCD04febb37-00d6-4279-8c5f-171950278c8f101
485485tizanidine 4 MG Oral CapsuleSCD70b1a815-8549-4602-af35-fdbedf5fad51101
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY70b1a815-8549-4602-af35-fdbedf5fad51101
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY04febb37-00d6-4279-8c5f-171950278c8f101
485485tiZANidine HCl 4 MG Oral CapsulePSNc46c7aa3-69db-82dc-e053-2995a90ac2519
485485tizanidine 4 MG Oral CapsuleSCDc46c7aa3-69db-82dc-e053-2995a90ac2519
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYc46c7aa3-69db-82dc-e053-2995a90ac2519
485486tiZANidine HCl 2 MG Oral CapsulePSNd7c97b79-da59-4e86-a01b-f91046d04f748
485485tiZANidine HCl 4 MG Oral CapsulePSNd7c97b79-da59-4e86-a01b-f91046d04f748
485484tiZANidine HCl 6 MG Oral CapsulePSNd7c97b79-da59-4e86-a01b-f91046d04f748
485486tizanidine 2 MG Oral CapsuleSCDd7c97b79-da59-4e86-a01b-f91046d04f748
485485tizanidine 4 MG Oral CapsuleSCDd7c97b79-da59-4e86-a01b-f91046d04f748
485484tizanidine 6 MG Oral CapsuleSCDd7c97b79-da59-4e86-a01b-f91046d04f748
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSYd7c97b79-da59-4e86-a01b-f91046d04f748
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYd7c97b79-da59-4e86-a01b-f91046d04f748
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYd7c97b79-da59-4e86-a01b-f91046d04f748
485485tiZANidine HCl 4 MG Oral CapsulePSNafd7e738-9cf4-7937-e053-2995a90a55bc5
485485tizanidine 4 MG Oral CapsuleSCDafd7e738-9cf4-7937-e053-2995a90a55bc5
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYafd7e738-9cf4-7937-e053-2995a90a55bc5
485486tiZANidine HCl 2 MG Oral CapsulePSN07b8db58-d037-477e-a62f-025e8a5afcb42
485485tiZANidine HCl 4 MG Oral CapsulePSN3f569c5a-ec9d-4356-ac04-c17714ff68d12
485485tiZANidine HCl 4 MG Oral CapsulePSN07b8db58-d037-477e-a62f-025e8a5afcb42
485484tiZANidine HCl 6 MG Oral CapsulePSN07b8db58-d037-477e-a62f-025e8a5afcb42
485486tizanidine 2 MG Oral CapsuleSCD07b8db58-d037-477e-a62f-025e8a5afcb42
485485tizanidine 4 MG Oral CapsuleSCD07b8db58-d037-477e-a62f-025e8a5afcb42
485485tizanidine 4 MG Oral CapsuleSCD3f569c5a-ec9d-4356-ac04-c17714ff68d12
485484tizanidine 6 MG Oral CapsuleSCD07b8db58-d037-477e-a62f-025e8a5afcb42
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY07b8db58-d037-477e-a62f-025e8a5afcb42
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY07b8db58-d037-477e-a62f-025e8a5afcb42
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY3f569c5a-ec9d-4356-ac04-c17714ff68d12
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY07b8db58-d037-477e-a62f-025e8a5afcb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-611-0567877061105500 CAPSULE in 1 BOTTLE (67877-611-05) 500 capsule2019-03-290000-00-00NoNoCurrent
67877-611-1567877061115150 CAPSULE in 1 BOTTLE (67877-611-15) 150 capsule2019-03-290000-00-00NoNoCurrent
67877-611-33678770611331 BLISTER PACK in 1 CARTON (67877-611-33) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2019-03-290000-00-00NoNoCurrent