FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
67296-1396
11-digit product format
672961396
Labeler code
67296
Product ID
67296-1396_d61b8590-e67a-5657-e053-2a95a90abdd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-07-22
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
2023-12-31
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
67296-1396-12024-01-30C16284748780-11030e365-55bb-111a-e063-dadaa90a10e2Cyclobenzaprine 10mg tabs
67296-1396-22024-01-30C16284748780-11030e365-55bb-111a-e063-dadaa90a10e2Cyclobenzaprine 10mg tabs
67296-1396-32024-01-30C16284748780-11030e365-55bb-111a-e063-dadaa90a10e2Cyclobenzaprine 10mg tabs
67296-1396-42024-01-30C16284748780-11030e365-55bb-111a-e063-dadaa90a10e2Cyclobenzaprine 10mg tabs
67296-1396-52024-01-30C16284748780-11030e365-55bb-111a-e063-dadaa90a10e2Cyclobenzaprine 10mg tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1396-1Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
67296-1396-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205
67296-1396-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
67296-1396-4Cyclobenzaprine Hydrochloride5 in 1 BOTTLETABLET, FILM COATED55
67296-1396-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1396CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]5Legacy NDC, 5 package rows20220122_50c28fda-7d64-08ce-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN50c28fda-7d64-08ce-e054-00144ff8d46c5
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD50c28fda-7d64-08ce-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1396-16729613960110 TABLET, FILM COATED in 1 BOTTLE (67296-1396-1) 2016-07-220000-00-00NoNoCurrent
67296-1396-26729613960220 TABLET, FILM COATED in 1 BOTTLE (67296-1396-2) 2016-07-220000-00-00NoNoCurrent
67296-1396-36729613960330 TABLET, FILM COATED in 1 BOTTLE (67296-1396-3) 2016-07-220000-00-00NoNoCurrent
67296-1396-4672961396045 TABLET, FILM COATED in 1 BOTTLE (67296-1396-4) 2016-07-220000-00-00NoNoCurrent
67296-1396-56729613960515 TABLET, FILM COATED in 1 BOTTLE (67296-1396-5) 2016-07-220000-00-00NoNoCurrent