FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
68387-140
11-digit product format
683870140
Labeler code
68387
Product ID
68387-140_8eba76b2-3510-40b2-a169-e8c1aea145e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA076347
Marketing category
ANDA
Marketing start
2005-06-01
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
E
Listing certified through
2017-12-31
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
68387-140-102019-10-21C16284748780-1956f9ecf-c1cb-621f-e053-dbdaa90a74adTizanidine hydrochloride Tablets
68387-140-302019-10-21C16284748780-1956f9ecf-c1cb-621f-e053-dbdaa90a74adTizanidine hydrochloride Tablets
68387-140-602019-10-21C16284748780-1956f9ecf-c1cb-621f-e053-dbdaa90a74adTizanidine hydrochloride Tablets
68387-140-902019-10-21C16284748780-1956f9ecf-c1cb-621f-e053-dbdaa90a74adTizanidine hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-140-10TIZANIDINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET103
68387-140-30TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET303
68387-140-60TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET603
68387-140-90TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-140-10EA - Each68387-14088a434c6-28d8-41a7-9fba-17d88f8983ed12012-07-24
68387-140-30EA - Each68387-140a486e9c6-d122-4f73-9dc2-aa6df4e41f3712012-07-24
68387-140-60EA - Each68387-14027ac9cdc-7107-4c51-b646-29a4e054dce912012-07-24
68387-140-90EA - Each68387-1407c2eb209-e0bc-46cc-989f-561ed432069512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-140TIZANIDINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]3Legacy NDC, 4 package rows20100713_0df212f5-f77b-4d94-8fd0-0b40d0e9a1c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313413tiZANidine HCl 4 MG Oral TabletPSN0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313412tizanidine 2 MG Oral TabletSCD0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313413tizanidine 4 MG Oral TabletSCD0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY0df212f5-f77b-4d94-8fd0-0b40d0e9a1c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-140-106838701401010 in 1 BOTTLE, PLASTICHistorical
68387-140-306838701403030 in 1 BOTTLE, PLASTICHistorical
68387-140-606838701406060 in 1 BOTTLE, PLASTICHistorical
68387-140-906838701409090 in 1 BOTTLE, PLASTICHistorical