FDA.reportPublic FDA data

Tizanidine Hydrochloride

Product NDC
46708-492
11-digit product format
467080492
Labeler code
46708
Product ID
46708-492_cf7c5bb7-d94b-4c98-a4a2-e6a917e4165b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213223
Marketing category
ANDA
Marketing start
2020-01-15
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
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 HYDROCHLORIDE4 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-492-082023-02-01C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996
46708-492-302023-02-01C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996
46708-492-412023-02-01C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996
46708-492-912023-02-01C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996
46708-492-082023-01-30C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996
46708-492-302023-01-30C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996
46708-492-412023-01-30C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996
46708-492-912023-01-30C16284748780-1f386c649-b1b3-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TIZANIDINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TIZANIDINE HYDROCHLORIDE CAPSULES. TIZANIDINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-492-08Tizanidine Hydrochloride8 in 1 BLISTER PACKCAPSULE82
46708-492-08Tizanidine Hydrochloride80 in 1 CARTONCAPSULE802
46708-492-30Tizanidine Hydrochloride30 in 1 BOTTLECAPSULE302
46708-492-41Tizanidine Hydrochloride150 in 1 BOTTLECAPSULE1502
46708-492-91Tizanidine Hydrochloride1000 in 1 BOTTLECAPSULE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-492TIZANIDINE HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 5 package rows20230202_29750221-497e-4747-a9b8-12a0c2236eae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSN29750221-497e-4747-a9b8-12a0c2236eae2
485485tiZANidine HCl 4 MG Oral CapsulePSN29750221-497e-4747-a9b8-12a0c2236eae2
485484tiZANidine HCl 6 MG Oral CapsulePSN29750221-497e-4747-a9b8-12a0c2236eae2
485486tizanidine 2 MG Oral CapsuleSCD29750221-497e-4747-a9b8-12a0c2236eae2
485485tizanidine 4 MG Oral CapsuleSCD29750221-497e-4747-a9b8-12a0c2236eae2
485484tizanidine 6 MG Oral CapsuleSCD29750221-497e-4747-a9b8-12a0c2236eae2
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY29750221-497e-4747-a9b8-12a0c2236eae2
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY29750221-497e-4747-a9b8-12a0c2236eae2
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY29750221-497e-4747-a9b8-12a0c2236eae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-492-084670804920880 BLISTER PACK in 1 CARTON (46708-492-08) / 8 CAPSULE in 1 BLISTER PACK80 blister pack2020-01-150000-00-00NoNoCurrent
46708-492-304670804923030 CAPSULE in 1 BOTTLE (46708-492-30) 30 capsule2020-01-150000-00-00NoNoCurrent
46708-492-4146708049241150 CAPSULE in 1 BOTTLE (46708-492-41) 150 capsule2020-01-150000-00-00NoNoCurrent
46708-492-91467080492911000 CAPSULE in 1 BOTTLE (46708-492-91) 1000 capsule2020-01-150000-00-00NoNoCurrent