Cyclobenzaprine Hydrochloride

Product NDC
50090-4946
11-digit product format
500904946
Labeler code
50090
Product ID
50090-4946_def4d617-e8fe-4433-960b-b4a538401d90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077797
Marketing category
ANDA
Marketing start
2007-02-28
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
2022-12-31
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
50090-4946-02023-01-30C16284748780-1f386c649-b7f8-0266-e053-dadaa90a7c1aCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4946-0Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED13
50090-4946-0Cyclobenzaprine Hydrochloride33 in 1 BOX, UNIT-DOSETABLET, FILM COATED333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4946CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210417_62d84ac1-32d8-4808-8b2f-99cd43ac1de8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN62d84ac1-32d8-4808-8b2f-99cd43ac1de83
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD62d84ac1-32d8-4808-8b2f-99cd43ac1de83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4946-05009049460033 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-4946-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK33 blister pack2020-02-280000-00-00NoNoCurrent