FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
61919-065
11-digit product format
619190065
Labeler code
61919
Product ID
61919-065_98767496-5afa-4b76-ae21-3f5dbd703fed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA090478
Marketing category
ANDA
Marketing start
2014-01-01
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
E
Listing certified through
2017-12-31
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
61919-065-152020-01-31C16284748780-19d75b9d0-226c-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE
61919-065-202020-01-31C16284748780-19d75b9d0-226c-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE
61919-065-602020-01-31C16284748780-19d75b9d0-226c-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE
61919-065-722020-01-31C16284748780-19d75b9d0-226c-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-065-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET155
61919-065-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET205
61919-065-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET305
61919-065-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET605
61919-065-72CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET1205
61919-065-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-065CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5Legacy NDC, 6 package rows20151102_5f2c5599-c4cd-47d6-83bb-a7cc1cf70db7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN5f2c5599-c4cd-47d6-83bb-a7cc1cf70db75
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD5f2c5599-c4cd-47d6-83bb-a7cc1cf70db75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-065-156191900651515 in 1 BOTTLEHistorical
61919-065-206191900652020 in 1 BOTTLEHistorical
61919-065-306191900653030 in 1 BOTTLEHistorical
61919-065-606191900656060 in 1 BOTTLEHistorical
61919-065-7261919006572120 in 1 BOTTLEHistorical
61919-065-906191900659090 in 1 BOTTLEHistorical