FDA.reportPublic FDA data

Tizanidine

Product NDC
29300-169
11-digit product format
293000169
Labeler code
29300
Product ID
29300-169_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
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
Tizanidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 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
29300-169-03Tizanidine300 in 1 BOTTLE, PLASTICTABLET30012
29300-169-05Tizanidine500 in 1 BOTTLE, PLASTICTABLET50012
29300-169-10Tizanidine1000 in 1 BOTTLE, PLASTICTABLET100012
29300-169-15Tizanidine150 in 1 BOTTLE, PLASTICTABLET15012
29300-169-19Tizanidine90 in 1 BOTTLE, PLASTICTABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-169TIZANIDINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]12Current NDC, Legacy NDC, 5 package rows20250529_a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletPSN9612d19b-9362-61ec-e053-2a95a90a04ce12
313413tiZANidine HCl 4 MG Oral TabletPSNf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tiZANidine HCl 4 MG Oral TabletPSNb14bd166-9f53-4f2e-be05-c447af04ef6912
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 TabletSCD9612d19b-9362-61ec-e053-2a95a90a04ce12
313413tizanidine 4 MG Oral TabletSCDa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313413tizanidine 4 MG Oral TabletSCDb14bd166-9f53-4f2e-be05-c447af04ef6912
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYb14bd166-9f53-4f2e-be05-c447af04ef6912
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 TabletSY9612d19b-9362-61ec-e053-2a95a90a04ce12
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYa3fa9c69-4baf-44f5-bac4-a19c34b0e1cb12
313413tiZANidine HCl 4 MG Oral TabletPSN308d2fdc-6136-4e75-95d3-342497add66c7
313413tiZANidine HCl 4 MG Oral TabletPSN047c67cd-7a63-49c9-b100-71651d3537ba7
313413tiZANidine HCl 4 MG Oral TabletPSNe13b111a-25b7-4fdd-a102-30f2996722f37
313413tiZANidine HCl 4 MG Oral TabletPSN6dd9946f-b2a4-1732-e053-2a91aa0a648f7
313413tiZANidine HCl 4 MG Oral TabletPSNafc96ee6-c99b-7283-e053-2a95a90ad14d7
313413tizanidine 4 MG Oral TabletSCD047c67cd-7a63-49c9-b100-71651d3537ba7
313413tizanidine 4 MG Oral TabletSCD308d2fdc-6136-4e75-95d3-342497add66c7
313413tizanidine 4 MG Oral TabletSCD6dd9946f-b2a4-1732-e053-2a91aa0a648f7
313413tizanidine 4 MG Oral TabletSCDe13b111a-25b7-4fdd-a102-30f2996722f37
313413tizanidine 4 MG Oral TabletSCDafc96ee6-c99b-7283-e053-2a95a90ad14d7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6dd9946f-b2a4-1732-e053-2a91aa0a648f7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY047c67cd-7a63-49c9-b100-71651d3537ba7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY308d2fdc-6136-4e75-95d3-342497add66c7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYe13b111a-25b7-4fdd-a102-30f2996722f37
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYafc96ee6-c99b-7283-e053-2a95a90ad14d7
313413tiZANidine HCl 4 MG Oral TabletPSN8877b79d-3084-8849-e053-2a95a90a3f3c6
313413tizanidine 4 MG Oral TabletSCD8877b79d-3084-8849-e053-2a95a90a3f3c6
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY8877b79d-3084-8849-e053-2a95a90a3f3c6
313413tiZANidine HCl 4 MG Oral TabletPSN8fa7e43d-dd27-4cbd-ae9f-1202dc5d649f2
313413tizanidine 4 MG Oral TabletSCD8fa7e43d-dd27-4cbd-ae9f-1202dc5d649f2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY8fa7e43d-dd27-4cbd-ae9f-1202dc5d649f2
313413tiZANidine HCl 4 MG Oral TabletPSN6e97c1ba-8171-4707-98ee-61afed75daac1
313413tiZANidine HCl 4 MG Oral TabletPSNbba33f22-bd11-3149-e053-2a95a90a85851
313413tiZANidine HCl 4 MG Oral TabletPSNea242c7d-b101-4197-8e65-b2b079e3b2b61
313413tiZANidine HCl 4 MG Oral TabletPSN9fd932fb-033c-4774-ac09-c823db8f97391
313413tizanidine 4 MG Oral TabletSCDbba33f22-bd11-3149-e053-2a95a90a85851
313413tizanidine 4 MG Oral TabletSCD6e97c1ba-8171-4707-98ee-61afed75daac1
313413tizanidine 4 MG Oral TabletSCDea242c7d-b101-4197-8e65-b2b079e3b2b61
313413tizanidine 4 MG Oral TabletSCD9fd932fb-033c-4774-ac09-c823db8f97391
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYbba33f22-bd11-3149-e053-2a95a90a85851
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYea242c7d-b101-4197-8e65-b2b079e3b2b61
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY9fd932fb-033c-4774-ac09-c823db8f97391
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6e97c1ba-8171-4707-98ee-61afed75daac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-169-0329300016903300 TABLET in 1 BOTTLE, PLASTIC (29300-169-03) 300 tablet2013-04-010000-00-00NoNoCurrent
29300-169-0529300016905500 TABLET in 1 BOTTLE, PLASTIC (29300-169-05) 500 tablet2013-04-010000-00-00NoNoCurrent
29300-169-10293000169101000 TABLET in 1 BOTTLE, PLASTIC (29300-169-10) 1000 tablet2013-04-010000-00-00NoNoCurrent
29300-169-1529300016915150 TABLET in 1 BOTTLE, PLASTIC (29300-169-15) 150 tablet2013-04-010000-00-00NoNoCurrent
29300-169-192930001691990 TABLET in 1 BOTTLE, PLASTIC (29300-169-19) 90 tablet2023-01-060000-00-00NoNoCurrent