FDA.reportPublic FDA data

TIZANDINE

Product NDC
61919-811
11-digit product format
619190811
Labeler code
61919
Product ID
61919-811_4c49db13-77a7-a9db-e063-6294a90a3197
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANDINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA091283
Marketing category
ANDA
Marketing start
2019-08-13
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 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
TIZANDINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412

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
61919-811-152025-01-30C16284748780-12cef2736-7e61-d83d-e063-dadaa90ab31fTIZANIDINE
61919-811-302025-01-30C16284748780-12cef2736-67f9-d83d-e063-dadaa90ab31fTIZANIDINE
61919-811-602025-01-30C16284748780-12cef2736-7a1a-d83d-e063-dadaa90ab31fTIZANIDINE
61919-811-722025-01-30C16284748780-12cef2736-797b-d83d-e063-dadaa90ab31fTIZANIDINE
61919-811-902025-01-30C16284748780-12cef2736-624f-d83d-e063-dadaa90ab31fTIZANIDINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-811-82TIZANDINE180 in 1 BOTTLETABLET1803
61919-811-90TIZANDINE90 in 1 BOTTLETABLET903
61919-811-15TIZANDINE15 in 1 BOTTLETABLET152
61919-811-30TIZANDINE30 in 1 BOTTLETABLET302
61919-811-72TIZANDINE120 in 1 BOTTLETABLET1202
61919-811-60TIZANDINE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-811-15EA - Each61919-811faa64e04-eb25-40b6-bc07-80eece048f2a12019-10-07
61919-811-30EA - Each61919-811820752f1-17d3-4787-b44e-4b245fa374b612020-02-13
61919-811-60EA - Each61919-811ba05ea46-343e-44a1-83bb-ff62650d779f12019-06-19
61919-811-72EA - Each61919-811017c9a87-ea3f-4ac0-a748-eec9e178614d12019-09-05
61919-811-90EA - Each61919-811604dff93-03bd-46f0-ac14-7cf59d33602f12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-811TIZANDINE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20221007_9b900366-2928-a644-e053-2a95a90ae676.zip
61919-811TIZANDINE TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 2 package rows20221007_9003cb5d-f9d6-7183-e053-2995a90ad6e8.zip
61919-811TIZANDINE TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20221007_93cac1fc-7e40-6583-e053-2a95a90a9dc7.zip
61919-811TIZANDINE TABLET [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20221007_9079fea5-ff32-9085-e053-2995a90a0766.zip
61919-811TIZANDINE TABLET [DIRECTRX]1Current NDC, Legacy NDC, 1 package rows20190502_87d9280d-684e-f5f5-e053-2a95a90aefdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN9003cb5d-f9d6-7183-e053-2995a90ad6e83
313412tizanidine 2 MG Oral TabletSCD9003cb5d-f9d6-7183-e053-2995a90ad6e83
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9003cb5d-f9d6-7183-e053-2995a90ad6e83
313412tiZANidine HCl 2 MG Oral TabletPSN9079fea5-ff32-9085-e053-2995a90a07662
313412tiZANidine HCl 2 MG Oral TabletPSN93cac1fc-7e40-6583-e053-2a95a90a9dc72
313412tiZANidine HCl 2 MG Oral TabletPSN9b900366-2928-a644-e053-2a95a90ae6762
313412tizanidine 2 MG Oral TabletSCD9079fea5-ff32-9085-e053-2995a90a07662
313412tizanidine 2 MG Oral TabletSCD93cac1fc-7e40-6583-e053-2a95a90a9dc72
313412tizanidine 2 MG Oral TabletSCD9b900366-2928-a644-e053-2a95a90ae6762
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9079fea5-ff32-9085-e053-2995a90a07662
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY93cac1fc-7e40-6583-e053-2a95a90a9dc72
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9b900366-2928-a644-e053-2a95a90ae6762
313412tiZANidine HCl 2 MG Oral TabletPSN87d9280d-684e-f5f5-e053-2a95a90aefdf1
313412tizanidine 2 MG Oral TabletSCD87d9280d-684e-f5f5-e053-2a95a90aefdf1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY87d9280d-684e-f5f5-e053-2a95a90aefdf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-811-156191908111515 TABLET in 1 BOTTLE (61919-811-15) 15 tablet2019-09-300000-00-00NoNoCurrent
61919-811-306191908113030 TABLET in 1 BOTTLE (61919-811-30) 30 tablet2020-01-080000-00-00NoNoCurrent
61919-811-606191908116060 TABLET in 1 BOTTLE (61919-811-60) 60 tablet2019-05-010000-00-00NoNoCurrent
61919-811-7261919081172120 TABLET in 1 BOTTLE (61919-811-72) 120 tablet2019-08-190000-00-00NoNoCurrent
61919-811-8261919081182180 TABLET in 1 BOTTLE (61919-811-82) 180 tablet2019-08-13NoNoHistorical
61919-811-906191908119090 TABLET in 1 BOTTLE (61919-811-90) 90 tablet2019-08-130000-00-00NoNoCurrent