Tizanidine

Product NDC
72789-327
11-digit product format
727890327
Labeler code
72789
Product ID
72789-327_40bb3624-175c-7967-e063-6394a90af2dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
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
72789-327-20Tizanidine20 in 1 BOTTLE, PLASTICTABLET2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-327-20EA - Each72789-3277e7e2f2f-f2b9-4d1a-b8ab-6f3e70ad914012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-327TIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]11Current NDC, 1 package rows20241011_fdf4f09d-4537-a438-e053-6394a90a573d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNfdf4f09d-4537-a438-e053-6394a90a573d12
313413tizanidine 4 MG Oral TabletSCDfdf4f09d-4537-a438-e053-6394a90a573d12
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYfdf4f09d-4537-a438-e053-6394a90a573d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-327-207278903272020 TABLET in 1 BOTTLE, PLASTIC (72789-327-20) 20 tablet2023-06-12NoNoCurrent