FDA.reportPublic FDA data

Tizanidine

Product NDC
35356-662
11-digit product format
353560662
Labeler code
35356
Product ID
35356-662_22a584c3-8b07-40b4-b70f-8857c268cebc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA076286
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
2027-03-31
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine

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
35356-662-14Tizanidine14 in 1 BOTTLETABLET143973
35356-662-18Tizanidine180 in 1 BOTTLETABLET1803973
35356-662-30Tizanidine30 in 1 BOTTLETABLET303973
35356-662-60Tizanidine60 in 1 BOTTLETABLET603973
35356-662-90Tizanidine90 in 1 BOTTLETABLET903973

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-662-14EA - Each35356-6624180611a-b03a-46e7-9787-a80709335c2912021-07-15
35356-662-18EA - Each35356-6626363df13-67ef-41fe-b6de-ca8141e5bcb412015-10-02
35356-662-30EA - Each35356-6628eca8346-ff35-44d1-b832-2437de6a149612013-02-13
35356-662-60EA - Each35356-662e8d4cabf-e20a-42c5-a004-af3f655687ff12013-02-13
35356-662-90EA - Each35356-6621419641e-e0c3-4a05-86ff-675b14d3b29812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
tizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-662TIZANIDINE TABLET [QUALITY CARE PRODUCTS, LLC]3973Current NDC, Legacy NDC, 5 package rows20241213_b68a9f81-7138-48cf-b987-b8d284e8105a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNb68a9f81-7138-48cf-b987-b8d284e8105a3973
313412tizanidine 2 MG Oral TabletSCDb68a9f81-7138-48cf-b987-b8d284e8105a3973
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYb68a9f81-7138-48cf-b987-b8d284e8105a3973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-662-143535606621414 TABLET in 1 BOTTLE (35356-662-14) 14 tablet2021-06-080000-00-00NoNoCurrent
35356-662-1835356066218180 TABLET in 1 BOTTLE (35356-662-18) 180 tablet2007-02-060000-00-00NoNoCurrent
35356-662-303535606623030 TABLET in 1 BOTTLE (35356-662-30) 30 tablet2007-02-062027-03-31NoNoCurrent
35356-662-603535606626060 TABLET in 1 BOTTLE (35356-662-60) 60 tablet2007-02-062026-12-31NoNoCurrent
35356-662-903535606629090 TABLET in 1 BOTTLE (35356-662-90) 90 tablet2007-02-062027-03-31NoNoCurrent