Cyclobenzaprine Hydrochloride

Product NDC
67296-1343
11-digit product format
672961343
Labeler code
67296
Product ID
67296-1343_d61fcab8-f1c8-e11f-e053-2a95a90aa91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, 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
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
67296-1343-22024-01-30C16284748780-11030e364-fe22-111a-e063-dadaa90a10e25036946e-7b6e-27c4-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1343-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1343CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20220123_5036946e-7b6e-27c4-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN5036946e-7b6e-27c4-e054-00144ff88e885
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD5036946e-7b6e-27c4-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1343-26729613430220 TABLET, FILM COATED in 1 BOTTLE (67296-1343-2) 2014-07-310000-00-00NoNoCurrent