Cyclobenzaprine Hydrochloride

Product NDC
45865-433
11-digit product format
458650433
Labeler code
45865
Product ID
45865-433_9ab23898-fc51-6937-e053-2a95a90ab577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090478
Marketing category
ANDA
Marketing start
2012-04-02
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-433-602025-01-30C16284748780-12cef2736-8fff-d83d-e063-dadaa90ab31fCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-433-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-433CYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_1db200b7-75d2-5e17-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1db200b7-75d2-5e17-e054-00144ff8d46c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1db200b7-75d2-5e17-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-433-604586504336060 TABLET in 1 BOTTLE (45865-433-60) 60 tablet2015-08-260000-00-00NoNoCurrent