FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
53002-0520
11-digit product format
530020520
Labeler code
53002
Product ID
53002-0520_5593a95c-bb68-491a-8fa1-896ab567cfe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078048
Marketing category
ANDA
Marketing start
2014-07-31
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
2021-12-31
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
53002-0520-12025-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-22025-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-32025-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-42025-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-52025-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-12023-06-07C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-22023-06-07C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-32023-06-07C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-42023-06-07C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-52023-06-07C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-12023-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-22023-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-32023-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-42023-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-52023-01-30C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-12020-12-15C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-22020-12-15C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-32020-12-15C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-42020-12-15C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-52020-12-15C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-12020-01-31C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-22020-01-31C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-32020-01-31C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-42020-01-31C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
53002-0520-52020-01-31C16284748780-19d75b9d0-17a7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0520-1Cyclobenzaprine Hydrochloride5 in 1 BOTTLETABLET, FILM COATED55
53002-0520-2Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
53002-0520-3Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED155
53002-0520-4Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205
53002-0520-5Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0520CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 5 package rows20230609_6d9dd102-855d-4be2-a9e6-5926f1dc3b4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN6d9dd102-855d-4be2-a9e6-5926f1dc3b4d5
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD6d9dd102-855d-4be2-a9e6-5926f1dc3b4d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0520-1530020520015 TABLET, FILM COATED in 1 BOTTLE (53002-0520-1) 2017-10-010000-00-00NoNoCurrent
53002-0520-25300205200210 TABLET, FILM COATED in 1 BOTTLE (53002-0520-2) 2017-10-010000-00-00NoNoCurrent
53002-0520-35300205200315 TABLET, FILM COATED in 1 BOTTLE (53002-0520-3) 2017-10-010000-00-00NoNoCurrent
53002-0520-45300205200420 TABLET, FILM COATED in 1 BOTTLE (53002-0520-4) 2017-10-010000-00-00NoNoCurrent
53002-0520-55300205200530 TABLET, FILM COATED in 1 BOTTLE (53002-0520-5) 2017-10-010000-00-00NoNoCurrent