FDA.reportPublic FDA data

Tizanidine Hydrochloride

Product NDC
62332-491
11-digit product format
623320491
Labeler code
62332
Product ID
62332-491_451990b5-d759-4025-9373-59f12ab8c267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213223
Marketing category
ANDA
Marketing start
2020-01-15
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485484, 485485, 485486

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
62332-491-08Tizanidine Hydrochloride80 in 1 CARTONCAPSULE806
62332-491-08Tizanidine Hydrochloride8 in 1 BLISTER PACKCAPSULE86
62332-491-30Tizanidine Hydrochloride30 in 1 BOTTLECAPSULE306
62332-491-41Tizanidine Hydrochloride150 in 1 BOTTLECAPSULE1506
62332-491-91Tizanidine Hydrochloride1000 in 1 BOTTLECAPSULE10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-491TIZANIDINE HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20250221_ee3e9813-a738-46d1-9c05-c931aee1495c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSNee3e9813-a738-46d1-9c05-c931aee1495c6
485485tiZANidine HCl 4 MG Oral CapsulePSNee3e9813-a738-46d1-9c05-c931aee1495c6
485484tiZANidine HCl 6 MG Oral CapsulePSNee3e9813-a738-46d1-9c05-c931aee1495c6
485486tizanidine 2 MG Oral CapsuleSCDee3e9813-a738-46d1-9c05-c931aee1495c6
485485tizanidine 4 MG Oral CapsuleSCDee3e9813-a738-46d1-9c05-c931aee1495c6
485484tizanidine 6 MG Oral CapsuleSCDee3e9813-a738-46d1-9c05-c931aee1495c6
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSYee3e9813-a738-46d1-9c05-c931aee1495c6
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYee3e9813-a738-46d1-9c05-c931aee1495c6
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYee3e9813-a738-46d1-9c05-c931aee1495c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-491-086233204910880 BLISTER PACK in 1 CARTON (62332-491-08) / 8 CAPSULE in 1 BLISTER PACK80 blister pack2020-01-150000-00-00NoNoCurrent
62332-491-306233204913030 CAPSULE in 1 BOTTLE (62332-491-30) 30 capsule2020-01-150000-00-00NoNoCurrent
62332-491-4162332049141150 CAPSULE in 1 BOTTLE (62332-491-41) 150 capsule2020-01-150000-00-00NoNoCurrent
62332-491-91623320491911000 CAPSULE in 1 BOTTLE (62332-491-91) 1000 capsule2020-01-150000-00-00NoNoCurrent