Tizanidne hydrochloride

Product NDC
67296-1793
11-digit product format
672961793
Labeler code
67296
Product ID
67296-1793_d61ccfc4-b180-7066-e053-2995a90a6318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA212196
Marketing category
ANDA
Marketing start
2019-03-29
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
67296-1793-72024-01-30C16284748780-11030e365-668f-111a-e063-dadaa90a10e2Tizanidine 4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1793-7Tizanidne hydrochloride15 in 1 BOTTLECAPSULE155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1793TIZANIDNE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20220123_afd7e738-9cf4-7937-e053-2995a90a55bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSNafd7e738-9cf4-7937-e053-2995a90a55bc5
485485tizanidine 4 MG Oral CapsuleSCDafd7e738-9cf4-7937-e053-2995a90a55bc5
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYafd7e738-9cf4-7937-e053-2995a90a55bc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1793-76729617930715 CAPSULE in 1 BOTTLE (67296-1793-7) 15 capsule2020-09-210000-00-00NoNoCurrent