FDA.reportPublic FDA data

Tizanidine

Product NDC
60760-694
11-digit product format
607600694
Labeler code
60760
Product ID
60760-694_3aaf2143-8057-ce13-e063-6394a90a5b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA076286
Marketing category
ANDA
Marketing start
2022-05-09
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

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
60760-694-04Tizanidine4 in 1 BOTTLE, PLASTICTABLET43
60760-694-15Tizanidine15 in 1 BOTTLE, PLASTICTABLET153
60760-694-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET303
60760-694-60Tizanidine60 in 1 BOTTLE, PLASTICTABLET603
60760-694-90Tizanidine90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-694-04EA - Each60760-6941c3b8132-0f09-4327-b65e-b5872139268012022-02-07
60760-694-15EA - Each60760-6947a273eb0-6d6d-4124-b7fc-c3dbb8280f1d12022-01-06
60760-694-30EA - Each60760-694c0c30ae6-ea43-4dde-816f-e69eb1d958f912025-06-13
60760-694-60EA - Each60760-694ef413df6-8529-474c-b42a-6c4782c28bbe12025-09-12
60760-694-90EA - Each60760-694dd7ba7b6-e2d7-49cc-876f-fcf6617144af12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-694TIZANIDINE TABLET [ST MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 3 package rows20250523_de99d950-9f01-9451-e053-2a95a90a9ec5.zip
60760-694TIZANIDINE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 2 package rows20211117_cfd52c0c-a7c2-e23d-e053-2a95a90abbd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNcfd52c0c-a7c2-e23d-e053-2a95a90abbd13
313412tiZANidine HCl 2 MG Oral TabletPSNde99d950-9f01-9451-e053-2a95a90a9ec53
313412tizanidine 2 MG Oral TabletSCDcfd52c0c-a7c2-e23d-e053-2a95a90abbd13
313412tizanidine 2 MG Oral TabletSCDde99d950-9f01-9451-e053-2a95a90a9ec53
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYcfd52c0c-a7c2-e23d-e053-2a95a90abbd13
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYde99d950-9f01-9451-e053-2a95a90a9ec53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-694-04607600694044 TABLET in 1 BOTTLE, PLASTIC (60760-694-04) 4 tablet2021-10-280000-00-00NoNoCurrent
60760-694-156076006941515 TABLET in 1 BOTTLE, PLASTIC (60760-694-15) 15 tablet2021-10-280000-00-00NoNoCurrent
60760-694-306076006943030 TABLET in 1 BOTTLE, PLASTIC (60760-694-30) 30 tablet2025-05-15NoNoHistorical
60760-694-606076006946060 TABLET in 1 BOTTLE, PLASTIC (60760-694-60) 60 tablet2025-07-24NoNoHistorical
60760-694-906076006949090 TABLET in 1 BOTTLE, PLASTIC (60760-694-90) 90 tablet2022-05-090000-00-00NoNoCurrent