FDA.reportPublic FDA data

tizanidine hydrochloride

Product NDC
68788-8776
11-digit product format
687888776
Labeler code
68788
Product ID
68788-8776_62f55001-6aa3-4baa-b6d2-564c09dab4ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213798
Marketing category
ANDA
Marketing start
2024-12-09
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 hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485485

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
68788-8776-1tizanidine hydrochloride100 in 1 BOTTLECAPSULE1002
68788-8776-2tizanidine hydrochloride20 in 1 BOTTLECAPSULE202
68788-8776-3tizanidine hydrochloride30 in 1 BOTTLECAPSULE302
68788-8776-6tizanidine hydrochloride60 in 1 BOTTLECAPSULE602
68788-8776-8tizanidine hydrochloride120 in 1 BOTTLECAPSULE1202
68788-8776-9tizanidine hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8776-1EA - Each68788-8776f2e6b60f-bdcc-4dbd-bae9-afe512760c1c12025-01-14
68788-8776-2EA - Each68788-8776e9c6afa0-ad7d-473d-98b4-0630a68957eb12025-01-14
68788-8776-3EA - Each68788-877644e07d78-f085-4b29-83f2-7c43a57791a912025-01-14
68788-8776-6EA - Each68788-87762c9bf18a-e917-45f4-9e96-24cc1851ed7012025-01-14
68788-8776-8EA - Each68788-87762a8e6c99-72fb-4ef9-a33d-ea34bccbe85212025-01-14
68788-8776-9EA - Each68788-8776c322bd95-e7eb-4be6-b056-b4aaabd4df2e12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8776TIZANIDINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20241211_ebccdb33-2b3c-4071-9765-8d95bcbc9b5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSNebccdb33-2b3c-4071-9765-8d95bcbc9b5f2
485485tizanidine 4 MG Oral CapsuleSCDebccdb33-2b3c-4071-9765-8d95bcbc9b5f2
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYebccdb33-2b3c-4071-9765-8d95bcbc9b5f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8776-168788877601100 CAPSULE in 1 BOTTLE (68788-8776-1) 100 capsule2024-12-09NoNoHistorical
68788-8776-26878887760220 CAPSULE in 1 BOTTLE (68788-8776-2) 20 capsule2024-12-09NoNoHistorical
68788-8776-36878887760330 CAPSULE in 1 BOTTLE (68788-8776-3) 30 capsule2024-12-09NoNoHistorical
68788-8776-66878887760660 CAPSULE in 1 BOTTLE (68788-8776-6) 60 capsule2024-12-09NoNoHistorical
68788-8776-868788877608120 CAPSULE in 1 BOTTLE (68788-8776-8) 120 capsule2024-12-09NoNoHistorical
68788-8776-96878887760990 CAPSULE in 1 BOTTLE (68788-8776-9) 90 capsule2024-12-09NoNoHistorical