FDA.reportPublic FDA data

Tizanidine

Product NDC
29300-168
11-digit product format
293000168
Labeler code
29300
Product ID
29300-168_06c83876-99c5-4ed1-8727-1a0d93452020
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412, 313413

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
29300-168-05Tizanidine500 in 1 BOTTLE, PLASTICTABLET50012
29300-168-10Tizanidine1000 in 1 BOTTLE, PLASTICTABLET100012
29300-168-15Tizanidine150 in 1 BOTTLE, PLASTICTABLET15012
29300-168-19Tizanidine90 in 1 BOTTLE, PLASTICTABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-168TIZANIDINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]12Current NDC, Legacy NDC, 4 package rows20250529_a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN615dfd5c-125a-40e2-a6da-afacde30528227
313412tizanidine 2 MG Oral TabletSCD615dfd5c-125a-40e2-a6da-afacde30528227
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY615dfd5c-125a-40e2-a6da-afacde30528227
313412tiZANidine HCl 2 MG Oral TabletPSN9678a98e-4aab-4d87-b5e1-37c3109e378e18
313412tizanidine 2 MG Oral TabletSCD9678a98e-4aab-4d87-b5e1-37c3109e378e18
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9678a98e-4aab-4d87-b5e1-37c3109e378e18
313412tiZANidine HCl 2 MG Oral TabletPSNf87e30ce-a60a-41e3-b5d6-7e296614396112
313412tiZANidine HCl 2 MG Oral TabletPSNa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313413tiZANidine HCl 4 MG Oral TabletPSNf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tiZANidine HCl 4 MG Oral TabletPSNa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313412tizanidine 2 MG Oral TabletSCDf87e30ce-a60a-41e3-b5d6-7e296614396112
313412tizanidine 2 MG Oral TabletSCDa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313413tizanidine 4 MG Oral TabletSCDf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tizanidine 4 MG Oral TabletSCDa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYf87e30ce-a60a-41e3-b5d6-7e296614396112
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313412tiZANidine HCl 2 MG Oral TabletPSN5b7b4721-e6fa-4586-ac40-091ad363ee855
313412tiZANidine HCl 2 MG Oral TabletPSNd2961d1c-5de2-0a2b-e053-2995a90ad2fc5
313412tizanidine 2 MG Oral TabletSCDd2961d1c-5de2-0a2b-e053-2995a90ad2fc5
313412tizanidine 2 MG Oral TabletSCD5b7b4721-e6fa-4586-ac40-091ad363ee855
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYd2961d1c-5de2-0a2b-e053-2995a90ad2fc5
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY5b7b4721-e6fa-4586-ac40-091ad363ee855
313412tiZANidine HCl 2 MG Oral TabletPSN9003cb5d-f9d6-7183-e053-2995a90ad6e83
313412tiZANidine HCl 2 MG Oral TabletPSN747b8a4f-3683-4b95-8cca-88b9be3b35263
313412tizanidine 2 MG Oral TabletSCD9003cb5d-f9d6-7183-e053-2995a90ad6e83
313412tizanidine 2 MG Oral TabletSCD747b8a4f-3683-4b95-8cca-88b9be3b35263
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY747b8a4f-3683-4b95-8cca-88b9be3b35263
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9003cb5d-f9d6-7183-e053-2995a90ad6e83
313412tiZANidine HCl 2 MG Oral TabletPSN9b900366-2928-a644-e053-2a95a90ae6762
313412tiZANidine HCl 2 MG Oral TabletPSN9079fea5-ff32-9085-e053-2995a90a07662
313412tiZANidine HCl 2 MG Oral TabletPSN93cac1fc-7e40-6583-e053-2a95a90a9dc72
313412tizanidine 2 MG Oral TabletSCD93cac1fc-7e40-6583-e053-2a95a90a9dc72
313412tizanidine 2 MG Oral TabletSCD9079fea5-ff32-9085-e053-2995a90a07662
313412tizanidine 2 MG Oral TabletSCD9b900366-2928-a644-e053-2a95a90ae6762
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 TabletSY9079fea5-ff32-9085-e053-2995a90a07662
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 HCl 2 MG Oral TabletPSNa3b676eb-c097-46f5-ba16-fd1dedf2f5eb1
313412tiZANidine HCl 2 MG Oral TabletPSN49adcfc8-3b1d-7f7e-e063-6294a90a361e1
313412tizanidine 2 MG Oral TabletSCD87d9280d-684e-f5f5-e053-2a95a90aefdf1
313412tizanidine 2 MG Oral TabletSCDa3b676eb-c097-46f5-ba16-fd1dedf2f5eb1
313412tizanidine 2 MG Oral TabletSCD49adcfc8-3b1d-7f7e-e063-6294a90a361e1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY87d9280d-684e-f5f5-e053-2a95a90aefdf1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY49adcfc8-3b1d-7f7e-e063-6294a90a361e1
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYa3b676eb-c097-46f5-ba16-fd1dedf2f5eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-168-0529300016805500 TABLET in 1 BOTTLE, PLASTIC (29300-168-05) 500 tablet2013-04-010000-00-00NoNoCurrent
29300-168-10293000168101000 TABLET in 1 BOTTLE, PLASTIC (29300-168-10) 1000 tablet2013-04-010000-00-00NoNoCurrent
29300-168-1529300016815150 TABLET in 1 BOTTLE, PLASTIC (29300-168-15) 150 tablet2013-04-010000-00-00NoNoCurrent
29300-168-192930001681990 TABLET in 1 BOTTLE, PLASTIC (29300-168-19) 90 tablet2023-01-060000-00-00NoNoCurrent