FDA.reportPublic FDA data

Tizanidine

Product NDC
43063-455
11-digit product format
430630455
Labeler code
43063
Product ID
43063-455_47d2acba-fb93-f1a3-e063-6394a90aa13f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

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
43063-455-15Tizanidine15 in 1 BOTTLE, PLASTICTABLET1530
43063-455-20Tizanidine20 in 1 BOTTLE, PLASTICTABLET2030
43063-455-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET3030
43063-455-40Tizanidine40 in 1 BOTTLE, PLASTICTABLET4030
43063-455-60Tizanidine60 in 1 BOTTLE, PLASTICTABLET6030
43063-455-90Tizanidine90 in 1 BOTTLE, PLASTICTABLET9030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-455-15EA - Each43063-4554d28cc65-ef1d-4a9f-9989-f408eccd5fbe12014-09-03
43063-455-20EA - Each43063-455aca89693-d212-4b36-8a18-82606182333112015-03-03
43063-455-30EA - Each43063-455d54c10cd-a9c0-44c7-871a-564d7ac4945312015-04-03
43063-455-40EA - Each43063-455e9dc51ba-0cd0-4780-a1b4-9a235b263bf612020-08-06
43063-455-60EA - Each43063-455abf8ea1d-e95b-4f8e-8ea8-0e4c611ba72812013-07-02
43063-455-90EA - Each43063-4558988503b-2ec7-4365-88b2-7466017aeb9a12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]11
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]11
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]11
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]11
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]11
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-455TIZANIDINE TABLET [PD-RX PHARMACEUTICALS, INC.]28Current NDC, Legacy NDC, 6 package rows20250316_ac897a5a-677b-4a6e-abb1-b810470200fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNac897a5a-677b-4a6e-abb1-b810470200fc30
313413tizanidine 4 MG Oral TabletSCDac897a5a-677b-4a6e-abb1-b810470200fc30
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYac897a5a-677b-4a6e-abb1-b810470200fc30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-455-154306304551515 TABLET in 1 BOTTLE, PLASTIC (43063-455-15) 15 tablet2016-11-220000-00-00NoNoCurrent
43063-455-204306304552020 TABLET in 1 BOTTLE, PLASTIC (43063-455-20) 20 tablet2016-11-220000-00-00NoNoCurrent
43063-455-304306304553030 TABLET in 1 BOTTLE, PLASTIC (43063-455-30) 30 tablet2016-11-220000-00-00NoNoCurrent
43063-455-404306304554040 TABLET in 1 BOTTLE, PLASTIC (43063-455-40) 40 tablet2020-06-010000-00-00NoNoCurrent
43063-455-604306304556060 TABLET in 1 BOTTLE, PLASTIC (43063-455-60) 60 tablet2020-06-010000-00-00NoNoCurrent
43063-455-904306304559090 TABLET in 1 BOTTLE, PLASTIC (43063-455-90) 90 tablet2020-06-010000-00-00NoNoCurrent