FDA.reportPublic FDA data

Tizanidine

Product NDC
60760-505
11-digit product format
607600505
Labeler code
60760
Product ID
60760-505_45754f79-3449-b984-e063-6394a90aeb18
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
2021-06-21
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
Rxcui313413

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
60760-505-04Tizanidine4 in 1 BOTTLE, PLASTICTABLET45
60760-505-15Tizanidine15 in 1 BOTTLE, PLASTICTABLET155
60760-505-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET305
60760-505-60Tizanidine60 in 1 BOTTLE, PLASTICTABLET605
60760-505-90Tizanidine90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-505-04EA - Each60760-5050c7852b0-bc2a-4d87-b530-6e3b3b6e0aca12021-12-08
60760-505-15EA - Each60760-50530062f16-280f-41c3-bb11-74400b3f618312021-08-05
60760-505-30EA - Each60760-505ee1aa84e-2fd3-4e2d-8c40-d280eb0be0d812021-11-09
60760-505-60EA - Each60760-5059928a718-265f-442a-89cf-172eac7fdeb212022-02-07
60760-505-90EA - Each60760-5056fcd2a4b-a0d9-4a94-9958-1a1b95af552212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-505TIZANIDINE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]4Current NDC, Legacy NDC, 5 package rows20211209_c6b4486f-e847-64ee-e053-2995a90a855a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNc6b4486f-e847-64ee-e053-2995a90a855a5
313413tizanidine 4 MG Oral TabletSCDc6b4486f-e847-64ee-e053-2995a90a855a5
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYc6b4486f-e847-64ee-e053-2995a90a855a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-505-04607600505044 TABLET in 1 BOTTLE, PLASTIC (60760-505-04) 4 tablet2021-10-040000-00-00NoNoCurrent
60760-505-156076005051515 TABLET in 1 BOTTLE, PLASTIC (60760-505-15) 15 tablet2021-06-210000-00-00NoNoCurrent
60760-505-306076005053030 TABLET in 1 BOTTLE, PLASTIC (60760-505-30) 30 tablet2021-07-300000-00-00NoNoCurrent
60760-505-606076005056060 TABLET in 1 BOTTLE, PLASTIC (60760-505-60) 60 tablet2021-11-100000-00-00NoNoCurrent
60760-505-906076005059090 TABLET in 1 BOTTLE, PLASTIC (60760-505-90) 90 tablet2021-12-080000-00-00NoNoCurrent