FDA.reportPublic FDA data

Tizanidine

Product NDC
72789-325
11-digit product format
727890325
Labeler code
72789
Product ID
72789-325_40bb3383-082a-7a68-e063-6394a90a8da3
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
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
72789-325-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET3020
72789-325-77Tizanidine150 in 1 BOTTLE, PLASTICTABLET15020
72789-325-90Tizanidine90 in 1 BOTTLE, PLASTICTABLET9020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-325TIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]19Current NDC, 3 package rows20241127_fd16a25c-67b6-ae6c-e053-6394a90aeee0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNfd16a25c-67b6-ae6c-e053-6394a90aeee020
313413tiZANidine HCl 4 MG Oral TabletPSNfd16a25c-67b6-ae6c-e053-6394a90aeee020
313412tizanidine 2 MG Oral TabletSCDfd16a25c-67b6-ae6c-e053-6394a90aeee020
313413tizanidine 4 MG Oral TabletSCDfd16a25c-67b6-ae6c-e053-6394a90aeee020
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYfd16a25c-67b6-ae6c-e053-6394a90aeee020
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYfd16a25c-67b6-ae6c-e053-6394a90aeee020
313413tiZANidine HCl 4 MG Oral TabletPSN25db7cc0-604c-3d6b-e063-6394a90a337f4
313413tizanidine 4 MG Oral TabletSCD25db7cc0-604c-3d6b-e063-6394a90a337f4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY25db7cc0-604c-3d6b-e063-6394a90a337f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-325-307278903253030 TABLET in 1 BOTTLE, PLASTIC (72789-325-30) 30 tablet2023-06-01NoNoCurrent
72789-325-7772789032577150 TABLET in 1 BOTTLE, PLASTIC (72789-325-77) 150 tablet2023-06-01NoNoCurrent
72789-325-907278903259090 TABLET in 1 BOTTLE, PLASTIC (72789-325-90) 90 tablet2023-06-02NoNoCurrent