FDA.reportPublic FDA data

Zanaflex

Product NDC
83107-004
11-digit product format
831070004
Labeler code
83107
Product ID
83107-004_476ae6e6-0732-af36-e063-6394a90a7c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharma USA, Inc.
Application
NDA020397
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83107-004-15Zanaflex150 in 1 BOTTLETABLET1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83107-004-15EA - Each83107-004cdbecb39-b0bb-4fa0-b423-c663c1da27a512026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83107-004ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE ZANAFLEX (TIZANIDINE HYDROCHLORIDE) TABLET [LEGACY PHARMA USA, INC.]1Current NDC, 1 package rows20241206_60c27d35-7349-4fc6-86ad-70fffdbe3e08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
485485tiZANidine HCl 4 MG Oral CapsulePSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
313413tiZANidine HCl 4 MG Oral TabletPSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
485484tiZANidine HCl 6 MG Oral CapsulePSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
583165Zanaflex 2 MG Oral CapsulePSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
583211Zanaflex 4 MG Oral CapsulePSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
153735Zanaflex 4 MG Oral TabletPSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
580267Zanaflex 6 MG Oral CapsulePSN60c27d35-7349-4fc6-86ad-70fffdbe3e082
583165tizanidine 2 MG Oral Capsule [Zanaflex]SBD60c27d35-7349-4fc6-86ad-70fffdbe3e082
583211tizanidine 4 MG Oral Capsule [Zanaflex]SBD60c27d35-7349-4fc6-86ad-70fffdbe3e082
153735tizanidine 4 MG Oral Tablet [Zanaflex]SBD60c27d35-7349-4fc6-86ad-70fffdbe3e082
580267tizanidine 6 MG Oral Capsule [Zanaflex]SBD60c27d35-7349-4fc6-86ad-70fffdbe3e082
485486tizanidine 2 MG Oral CapsuleSCD60c27d35-7349-4fc6-86ad-70fffdbe3e082
485485tizanidine 4 MG Oral CapsuleSCD60c27d35-7349-4fc6-86ad-70fffdbe3e082
313413tizanidine 4 MG Oral TabletSCD60c27d35-7349-4fc6-86ad-70fffdbe3e082
485484tizanidine 6 MG Oral CapsuleSCD60c27d35-7349-4fc6-86ad-70fffdbe3e082
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
583165Zanaflex 2 MG (tizanidine hydrochloride 2.29 MG) Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
583165Zanaflex 2 MG Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
583211Zanaflex 4 MG (tizanidine hydrochloride 4.58 MG) Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
153735Zanaflex 4 MG (tizanidine hydrochloride 4.58 MG) Oral TabletSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
583211Zanaflex 4 MG Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
153735Zanaflex 4 MG Oral TabletSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
580267Zanaflex 6 MG (tizanidine hydrochloride 6.87 MG) Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082
580267Zanaflex 6 MG Oral CapsuleSY60c27d35-7349-4fc6-86ad-70fffdbe3e082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83107-004-1583107000415150 TABLET in 1 BOTTLE (83107-004-15) 150 tablet2018-08-01NoNoHistorical