FDA.reportPublic FDA data

Zanaflex

Product NDC
70515-604
11-digit product format
705150604
Labeler code
70515
Product ID
70515-604_3468e009-cfd1-f217-e063-6294a90a1429
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Covis Pharma US, Inc
Application
NDA021447
Marketing category
NDA
Marketing start
2018-08-01
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
Zanaflex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70515-604-152025-02-11C16284748780-11e7a6dab-190e-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use ZANAFLEX ® safely and effectively. See full prescribing information for ZANAFLEX. ZANAFLEX ® (tizanidine hydrochloride) capsules, for oral use ZANAFLEX ® (tizanidine hydrochloride) tablets, for oral use Initial U.S. Approval: 1996
70515-604-152025-01-30C16284748780-11e7a6dab-190e-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use ZANAFLEX ® safely and effectively. See full prescribing information for ZANAFLEX. ZANAFLEX ® (tizanidine hydrochloride) capsules, for oral use ZANAFLEX ® (tizanidine hydrochloride) tablets, for oral use Initial U.S. Approval: 1996
70515-604-152024-07-30C16284748780-11e7a6dab-190e-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use ZANAFLEX ® safely and effectively. See full prescribing information for ZANAFLEX. ZANAFLEX ® (tizanidine hydrochloride) capsules, for oral use ZANAFLEX ® (tizanidine hydrochloride) tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70515-604-15Zanaflex150 in 1 BOTTLECAPSULE1506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70515-604-15EA - Each70515-604c4918030-86ca-4aa9-9a1a-ca11ef9740cf12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70515-604ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [COVIS PHARMA US, INC]6Current NDC, Legacy NDC, 1 package rows20250507_043d9e51-bfa2-4add-9058-5ece332f7e99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSN043d9e51-bfa2-4add-9058-5ece332f7e996
485485tiZANidine HCl 4 MG Oral CapsulePSN043d9e51-bfa2-4add-9058-5ece332f7e996
313413tiZANidine HCl 4 MG Oral TabletPSN043d9e51-bfa2-4add-9058-5ece332f7e996
485484tiZANidine HCl 6 MG Oral CapsulePSN043d9e51-bfa2-4add-9058-5ece332f7e996
583165Zanaflex 2 MG Oral CapsulePSN043d9e51-bfa2-4add-9058-5ece332f7e996
583211Zanaflex 4 MG Oral CapsulePSN043d9e51-bfa2-4add-9058-5ece332f7e996
153735Zanaflex 4 MG Oral TabletPSN043d9e51-bfa2-4add-9058-5ece332f7e996
580267Zanaflex 6 MG Oral CapsulePSN043d9e51-bfa2-4add-9058-5ece332f7e996
583165tizanidine 2 MG Oral Capsule [Zanaflex]SBD043d9e51-bfa2-4add-9058-5ece332f7e996
583211tizanidine 4 MG Oral Capsule [Zanaflex]SBD043d9e51-bfa2-4add-9058-5ece332f7e996
153735tizanidine 4 MG Oral Tablet [Zanaflex]SBD043d9e51-bfa2-4add-9058-5ece332f7e996
580267tizanidine 6 MG Oral Capsule [Zanaflex]SBD043d9e51-bfa2-4add-9058-5ece332f7e996
485486tizanidine 2 MG Oral CapsuleSCD043d9e51-bfa2-4add-9058-5ece332f7e996
485485tizanidine 4 MG Oral CapsuleSCD043d9e51-bfa2-4add-9058-5ece332f7e996
313413tizanidine 4 MG Oral TabletSCD043d9e51-bfa2-4add-9058-5ece332f7e996
485484tizanidine 6 MG Oral CapsuleSCD043d9e51-bfa2-4add-9058-5ece332f7e996
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY043d9e51-bfa2-4add-9058-5ece332f7e996
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
583165Zanaflex 2 MG (tizanidine hydrochloride 2.29 MG) Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
583165Zanaflex 2 MG Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
583211Zanaflex 4 MG (tizanidine hydrochloride 4.58 MG) Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
153735Zanaflex 4 MG (tizanidine hydrochloride 4.58 MG) Oral TabletSY043d9e51-bfa2-4add-9058-5ece332f7e996
583211Zanaflex 4 MG Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
153735Zanaflex 4 MG Oral TabletSY043d9e51-bfa2-4add-9058-5ece332f7e996
580267Zanaflex 6 MG (tizanidine hydrochloride 6.87 MG) Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996
580267Zanaflex 6 MG Oral CapsuleSY043d9e51-bfa2-4add-9058-5ece332f7e996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70515-604-1570515060415150 CAPSULE in 1 BOTTLE (70515-604-15) 150 capsule2018-08-010000-00-00NoNoCurrent