Cyclobenzaprine Hydrochloride

Product NDC
50090-4105
11-digit product format
500904105
Labeler code
50090
Product ID
50090-4105_352b78dd-14aa-4a18-b5b1-fd4dfeb61be1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 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
50090-4105-02023-01-30C16284748780-1f386c64a-08f9-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only
50090-4105-12023-01-30C16284748780-1f386c64a-08f9-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4105-0Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
50090-4105-1Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4105CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20190501_ba142223-1c8b-4ea6-b531-37f7b2dddf66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNba142223-1c8b-4ea6-b531-37f7b2dddf664
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDba142223-1c8b-4ea6-b531-37f7b2dddf664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4105-05009041050030 TABLET, FILM COATED in 1 BOTTLE (50090-4105-0) 2019-01-290000-00-00NoNoCurrent
50090-4105-15009041050120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4105-1) 2014-11-280000-00-00NoNoCurrent