FDA.reportPublic FDA data

Tizanidine

Product NDC
85509-1180
11-digit product format
855091180
Labeler code
85509
Product ID
85509-1180_3a7b7ba1-4796-0e38-e063-6294a90a44fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
PHOENIX RX LLC
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
85509-1180-1Tizanidine120 in 1 BOTTLETABLET1201
85509-1180-2Tizanidine28 in 1 BOTTLETABLET281
85509-1180-3Tizanidine30 in 1 BOTTLETABLET301
85509-1180-6Tizanidine60 in 1 BOTTLETABLET601
85509-1180-9Tizanidine90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1180-1EA - Each85509-11807b1c1812-5666-4516-b3e9-41bec7e896a112025-09-12
85509-1180-2EA - Each85509-118029c6fa0e-dec5-4c64-8fda-0a983b82a78512025-09-12
85509-1180-3EA - Each85509-1180db231d28-fd40-44b3-9aa9-6a1ab320e71d12025-09-12
85509-1180-6EA - Each85509-11807beefe3d-c31e-4c73-bf76-e80a66ae99da12025-09-12
85509-1180-9EA - Each85509-118004747b45-fccf-4652-bc9b-869bde20076812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN3a7b9b9a-9bf9-0b37-e063-6294a90a1c391
313413tizanidine 4 MG Oral TabletSCD3a7b9b9a-9bf9-0b37-e063-6294a90a1c391
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY3a7b9b9a-9bf9-0b37-e063-6294a90a1c391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-1180-185509118001120 TABLET in 1 BOTTLE (85509-1180-1) 120 tablet2025-07-31NoNoHistorical
85509-1180-28550911800228 TABLET in 1 BOTTLE (85509-1180-2) 28 tablet2025-07-31NoNoHistorical
85509-1180-38550911800330 TABLET in 1 BOTTLE (85509-1180-3) 30 tablet2025-07-31NoNoHistorical
85509-1180-68550911800660 TABLET in 1 BOTTLE (85509-1180-6) 60 tablet2025-07-31NoNoHistorical
85509-1180-98550911800990 TABLET in 1 BOTTLE (85509-1180-9) 90 tablet2025-07-31NoNoHistorical