FDA.reportPublic FDA data

Tizanidine

Product NDC
63187-910
11-digit product format
631870910
Labeler code
63187
Product ID
63187-910_fdcb382b-4753-45e8-ab3c-28d929c764b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

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
63187-910-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET305
63187-910-60Tizanidine60 in 1 BOTTLE, PLASTICTABLET605
63187-910-90Tizanidine90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-910-30EA - Each63187-910db9fcff0-6bd6-4974-81bb-ccbcdcc4ef6012019-04-11
63187-910-60EA - Each63187-9103c74aff2-e25c-48d2-99c8-b202bd45042512017-11-06
63187-910-90EA - Each63187-91056a09b29-6880-4985-aef8-4d25ce845f9912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-910TIZANIDINE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220409_5b7b4721-e6fa-4586-ac40-091ad363ee85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN5b7b4721-e6fa-4586-ac40-091ad363ee855
313412tizanidine 2 MG Oral TabletSCD5b7b4721-e6fa-4586-ac40-091ad363ee855
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY5b7b4721-e6fa-4586-ac40-091ad363ee855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-910-306318709103030 TABLET in 1 BOTTLE, PLASTIC (63187-910-30) 30 tablet2017-09-010000-00-00NoNoCurrent
63187-910-606318709106060 TABLET in 1 BOTTLE, PLASTIC (63187-910-60) 60 tablet2017-09-010000-00-00NoNoCurrent
63187-910-906318709109090 TABLET in 1 BOTTLE, PLASTIC (63187-910-90) 90 tablet2017-09-010000-00-00NoNoCurrent