FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
50090-4024
11-digit product format
500904024
Labeler code
50090
Product ID
50090-4024_8b046778-e245-43f6-b715-3cc9bcacee1a
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
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
50090-4024-02023-01-30C16284748780-1f386c649-c561-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only
50090-4024-12023-01-30C16284748780-1f386c649-c561-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only
50090-4024-42023-01-30C16284748780-1f386c649-c561-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only
50090-4024-62023-01-30C16284748780-1f386c649-c561-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only
50090-4024-72023-01-30C16284748780-1f386c649-c561-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only
50090-4024-92023-01-30C16284748780-1f386c649-c561-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4024-0Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED154
50090-4024-1Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED204
50090-4024-4Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
50090-4024-6Cyclobenzaprine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET, FILM COATED74
50090-4024-7Cyclobenzaprine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED144
50090-4024-9Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4024CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 6 package rows20190501_b8ee8ddd-44ff-4149-9969-519fef14938a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb8ee8ddd-44ff-4149-9969-519fef14938a4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb8ee8ddd-44ff-4149-9969-519fef14938a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4024-05009040240015 TABLET, FILM COATED in 1 BOTTLE (50090-4024-0) 2019-01-080000-00-00NoNoCurrent
50090-4024-15009040240120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4024-1) 2014-11-280000-00-00NoNoCurrent
50090-4024-450090402404100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4024-4) 2014-11-280000-00-00NoNoCurrent
50090-4024-6500904024067 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4024-6) 2014-11-280000-00-00NoNoCurrent
50090-4024-75009040240714 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4024-7) 2014-11-280000-00-00NoNoCurrent
50090-4024-95009040240910 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4024-9) 2014-11-280000-00-00NoNoCurrent