Cyclobenzaprine Hydrochloride

Product NDC
64205-541
11-digit product format
642050541
Labeler code
64205
Product ID
64205-541_d7a25b18-8774-42b7-afff-cf78a0f05274
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ReadyMeds
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64205-541-302019-11-27C16284748780-19855e2a2-3963-60a7-e053-dbdaa90a05bdCyclobenzaprine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-541-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-541CYCLOBENZAPRINE HYDROCHLORIDE TABLET [READYMEDS]5Legacy NDC, 1 package rows20140515_ad306e55-6c89-4d14-a553-2ac776b4dd28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNad306e55-6c89-4d14-a553-2ac776b4dd285
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDad306e55-6c89-4d14-a553-2ac776b4dd285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-541-306420505413030 in 1 BOTTLEHistorical