FDA.reportPublic FDA data

Tizanidine

Product NDC
43063-868
11-digit product format
430630868
Labeler code
43063
Product ID
43063-868_3a214bf4-ea51-0892-e063-6394a90a9a9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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

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
43063-868-12Tizanidine12 in 1 BOTTLE, PLASTICTABLET1227
43063-868-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET3027
43063-868-60Tizanidine60 in 1 BOTTLE, PLASTICTABLET6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-868-12EA - Each43063-86893a9d016-2d0d-473c-8676-56cc691b773612018-08-13
43063-868-30EA - Each43063-868211fb1df-620a-43dd-be7b-c677a6ddcc9b12018-08-13
43063-868-60EA - Each43063-868ceabb1b6-a91b-4694-9ae1-16e84c45bedf12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-868TIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 3 package rows20250413_615dfd5c-125a-40e2-a6da-afacde305282.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-868-124306308681212 TABLET in 1 BOTTLE, PLASTIC (43063-868-12) 12 tablet2018-07-090000-00-00NoNoCurrent
43063-868-304306308683030 TABLET in 1 BOTTLE, PLASTIC (43063-868-30) 30 tablet2018-07-090000-00-00NoNoCurrent
43063-868-604306308686060 TABLET in 1 BOTTLE, PLASTIC (43063-868-60) 60 tablet2018-07-090000-00-00NoNoCurrent