Cyclobenzaprine Hydrochloride

Product NDC
67296-0447
11-digit product format
672960447
Labeler code
67296
Product ID
67296-0447_dcde7446-4610-452d-ac4b-9eb57f78c252
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA078218
Marketing category
ANDA
Marketing start
2010-02-18
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0447-1Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET151
67296-0447-2Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET101
67296-0447-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301
67296-0447-4Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET201

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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE 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
67296-0447CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1Legacy NDC, 4 package rows20110824_fae7e4a7-ca63-4af4-a43a-c5d85cce1961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNfae7e4a7-ca63-4af4-a43a-c5d85cce19611
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDfae7e4a7-ca63-4af4-a43a-c5d85cce19611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0447-16729604470115 in 1 BOTTLEHistorical
67296-0447-26729604470210 in 1 BOTTLEHistorical
67296-0447-36729604470330 in 1 BOTTLEHistorical
67296-0447-46729604470420 in 1 BOTTLEHistorical