FDA.reportPublic FDA data

Tizanidine HCl

Product NDC
80425-0425
11-digit product format
804250425
Labeler code
80425
Product ID
80425-0425_45116bd8-f15b-9af1-e063-6294a90a1144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA076286
Marketing category
ANDA
Marketing start
2024-07-06
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 HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412, 313413

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
80425-0425-1Tizanidine HCl30 in 1 BOTTLETABLET309
80425-0425-2Tizanidine HCl60 in 1 BOTTLETABLET609
80425-0425-3Tizanidine HCl90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0425-1EA - Each80425-0425ecd194e3-786e-4e75-a713-571c8713811112024-09-09
80425-0425-2EA - Each80425-042528ab1880-5935-4467-9cc1-deec0793282012024-09-09
80425-0425-3EA - Each80425-04256ad7aec3-fbff-44e2-995f-69e52c64e09712024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0425TIZANIDINE HCL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, 3 package rows20240807_afc90292-c6bf-2d96-e053-2995a90abf00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNafc90292-c6bf-2d96-e053-2995a90abf009
313413tiZANidine HCl 4 MG Oral TabletPSNafc90292-c6bf-2d96-e053-2995a90abf009
313412tizanidine 2 MG Oral TabletSCDafc90292-c6bf-2d96-e053-2995a90abf009
313413tizanidine 4 MG Oral TabletSCDafc90292-c6bf-2d96-e053-2995a90abf009
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYafc90292-c6bf-2d96-e053-2995a90abf009
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYafc90292-c6bf-2d96-e053-2995a90abf009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0425-18042504250130 TABLET in 1 BOTTLE (80425-0425-1) 30 tablet2024-08-06NoNoHistorical
80425-0425-28042504250260 TABLET in 1 BOTTLE (80425-0425-2) 60 tablet2024-08-06NoNoHistorical
80425-0425-38042504250390 TABLET in 1 BOTTLE (80425-0425-3) 90 tablet2024-08-06NoNoHistorical