FDA.reportPublic FDA data

Tizanidine

Product NDC
71335-2325
11-digit product format
713352325
Labeler code
71335
Product ID
71335-2325_3c16209f-1ef5-4738-b6c1-eb3afac50967
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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
71335-2325-0Tizanidine112 in 1 BOTTLETABLET112101
71335-2325-1Tizanidine30 in 1 BOTTLETABLET30101
71335-2325-2Tizanidine60 in 1 BOTTLETABLET60101
71335-2325-3Tizanidine90 in 1 BOTTLETABLET90101
71335-2325-4Tizanidine120 in 1 BOTTLETABLET120101
71335-2325-5Tizanidine20 in 1 BOTTLETABLET20101
71335-2325-6Tizanidine45 in 1 BOTTLETABLET45101
71335-2325-7Tizanidine140 in 1 BOTTLETABLET140101
71335-2325-8Tizanidine84 in 1 BOTTLETABLET84101
71335-2325-9Tizanidine28 in 1 BOTTLETABLET28101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2325-1EA - Each71335-2325d2050b2f-c8af-44ef-b4d6-c05e2f2ebdd912025-03-04
71335-2325-2EA - Each71335-2325badf6204-7e61-4166-8546-52b26bb9ad5912025-01-14
71335-2325-3EA - Each71335-2325c1dbfdc0-5a57-4c1a-bd34-5269ac914a9412024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2325TIZANIDINE TABLET [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20240820_492c99bd-2cd0-43be-bd70-800b739b7e83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN492c99bd-2cd0-43be-bd70-800b739b7e83101
313413tizanidine 4 MG Oral TabletSCD492c99bd-2cd0-43be-bd70-800b739b7e83101
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY492c99bd-2cd0-43be-bd70-800b739b7e83101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2325-071335232500112 TABLET in 1 BOTTLE (71335-2325-0) 112 tablet2024-01-08NoNoHistorical
71335-2325-17133523250130 TABLET in 1 BOTTLE (71335-2325-1) 30 tablet2024-01-08NoNoHistorical
71335-2325-27133523250260 TABLET in 1 BOTTLE (71335-2325-2) 60 tablet2024-01-08NoNoHistorical
71335-2325-37133523250390 TABLET in 1 BOTTLE (71335-2325-3) 90 tablet2024-01-08NoNoHistorical
71335-2325-471335232504120 TABLET in 1 BOTTLE (71335-2325-4) 120 tablet2024-01-08NoNoHistorical
71335-2325-57133523250520 TABLET in 1 BOTTLE (71335-2325-5) 20 tablet2024-01-08NoNoHistorical
71335-2325-67133523250645 TABLET in 1 BOTTLE (71335-2325-6) 45 tablet2024-01-08NoNoHistorical
71335-2325-771335232507140 TABLET in 1 BOTTLE (71335-2325-7) 140 tablet2024-01-08NoNoHistorical
71335-2325-87133523250884 TABLET in 1 BOTTLE (71335-2325-8) 84 tablet2024-01-08NoNoHistorical
71335-2325-97133523250928 TABLET in 1 BOTTLE (71335-2325-9) 28 tablet2024-01-08NoNoHistorical