FDA.reportPublic FDA data

Tizanidine

Product NDC
70518-3658
11-digit product format
705183658
Labeler code
70518
Product ID
70518-3658_4f70b06b-e191-3fd4-e063-6394a90a43be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2023-02-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

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
70518-3658-0Tizanidine30 in 1 BLISTER PACKTABLET309
70518-3658-1Tizanidine90 in 1 BOTTLE, PLASTICTABLET909
70518-3658-2Tizanidine60 in 1 BOTTLE, PLASTICTABLET609
70518-3658-3Tizanidine15 in 1 BOTTLE, PLASTICTABLET159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3658-1EA - Each70518-3658ce3a398d-5783-4968-b374-e910cbe7430412026-02-05
70518-3658-2EA - Each70518-36588aa0e6ca-c535-4f61-88b9-b0bb80a0be3812026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3658TIZANIDINE TABLET [REMEDYREPACK INC.]6Current NDC, 4 package rows20250503_9bcc7f09-d2b5-4602-aaf3-5410b55ce275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN9bcc7f09-d2b5-4602-aaf3-5410b55ce2759
313413tizanidine 4 MG Oral TabletSCD9bcc7f09-d2b5-4602-aaf3-5410b55ce2759
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY9bcc7f09-d2b5-4602-aaf3-5410b55ce2759

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3658-07051836580030 TABLET in 1 BLISTER PACK (70518-3658-0) 30 tablet2023-02-23NoNoHistorical
70518-3658-17051836580190 in 1 BOTTLE, PLASTICHistorical
70518-3658-27051836580260 TABLET in 1 BOTTLE, PLASTIC (70518-3658-2) 60 tablet2023-06-19NoNoHistorical
70518-3658-37051836580315 TABLET in 1 BOTTLE, PLASTIC (70518-3658-3) 15 tablet2023-07-11NoNoHistorical