FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
21695-127
11-digit product format
216950127
Labeler code
21695
Product ID
21695-127_03fa46db-3676-4e0b-876d-5d226036b73e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors
Application
ANDA076347
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
0000-00-00
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-127-142019-09-24C16284748780-1934fe258-4986-48b1-e053-8cdaa90a720aTIZANIDINE HYDROCHLORIDE
21695-127-152019-09-24C16284748780-1934fe258-4986-48b1-e053-8cdaa90a720aTIZANIDINE HYDROCHLORIDE
21695-127-302019-09-24C16284748780-1934fe258-4986-48b1-e053-8cdaa90a720aTIZANIDINE HYDROCHLORIDE
21695-127-602019-09-24C16284748780-1934fe258-4986-48b1-e053-8cdaa90a720aTIZANIDINE HYDROCHLORIDE
21695-127-722019-09-24C16284748780-1934fe258-4986-48b1-e053-8cdaa90a720aTIZANIDINE HYDROCHLORIDE
21695-127-902019-09-24C16284748780-1934fe258-4986-48b1-e053-8cdaa90a720aTIZANIDINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-127-14TIZANIDINE HYDROCHLORIDE14 in 1 BOTTLETABLET141
21695-127-15TIZANIDINE HYDROCHLORIDE15 in 1 BOTTLETABLET151
21695-127-30TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLETABLET301
21695-127-60TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLETABLET601
21695-127-72TIZANIDINE HYDROCHLORIDE120 in 1 BOTTLETABLET1201
21695-127-90TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-127-14EA - Each21695-1277727172d-feff-4a1a-af4e-de3e61d7c1cc12012-07-24
21695-127-15EA - Each21695-1274ea7da2f-67c6-4b9c-82c3-7eec4bba698912012-07-24
21695-127-30EA - Each21695-127ef5acb4f-e58b-45a4-9c39-714b68f96e5212012-07-24
21695-127-60EA - Each21695-12775dedb8a-34c4-4952-801a-0ef39c65621512012-07-24
21695-127-72EA - Each21695-127a09058ab-ddf6-4990-8c47-9d5d5a26144d12012-07-24
21695-127-90EA - Each21695-127f4c7149f-a033-4ad1-ac53-bae48291d70512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-127TIZANIDINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1Legacy NDC, 6 package rows20100304_4f0d83de-0810-4255-8114-443f8fb915de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN4f0d83de-0810-4255-8114-443f8fb915de1
313413tiZANidine HCl 4 MG Oral TabletPSN4f0d83de-0810-4255-8114-443f8fb915de1
313412tizanidine 2 MG Oral TabletSCD4f0d83de-0810-4255-8114-443f8fb915de1
313413tizanidine 4 MG Oral TabletSCD4f0d83de-0810-4255-8114-443f8fb915de1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY4f0d83de-0810-4255-8114-443f8fb915de1
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY4f0d83de-0810-4255-8114-443f8fb915de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-127-142169501271414 in 1 BOTTLEHistorical
21695-127-152169501271515 in 1 BOTTLEHistorical
21695-127-302169501273030 in 1 BOTTLEHistorical
21695-127-602169501276060 in 1 BOTTLEHistorical
21695-127-7221695012772120 in 1 BOTTLEHistorical
21695-127-902169501279090 in 1 BOTTLEHistorical