Cyclobenzaprine Hydrochloride

Product NDC
67296-0053
11-digit product format
672960053
Labeler code
67296
Product ID
67296-0053_c9a70da5-765d-4c5d-a80c-34856c88338e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA077797
Marketing category
ANDA
Marketing start
2007-01-01
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
67296-0053-22019-10-29C16284748780-1960f7f55-dacc-8e05-e053-dbdaa90a074aCyclobenzaprine HCL Tablets
67296-0053-32019-10-29C16284748780-1960f7f55-dacc-8e05-e053-dbdaa90a074aCyclobenzaprine HCL Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0053-2Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET101
67296-0053-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cyclobenzaprine HydrochlorideACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
CyclobenzaprineACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0053CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1Legacy NDC, 2 package rows20110711_1534e79c-12cf-493e-8034-c1083f900ff5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1534e79c-12cf-493e-8034-c1083f900ff51
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1534e79c-12cf-493e-8034-c1083f900ff51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0053-26729600530210 in 1 BOTTLEHistorical
67296-0053-36729600530330 in 1 BOTTLEHistorical