FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
65162-540
11-digit product format
651620540
Labeler code
65162
Product ID
65162-540_df260758-80f8-4668-884c-7fb21600db2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078218
Marketing category
ANDA
Marketing start
2010-02-18
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320, 828348

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
65162-540-102021-01-28C16284748780-19d75b9d1-01bf-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-540-112021-01-28C16284748780-19d75b9d1-01bf-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-540-502021-01-28C16284748780-19d75b9d1-01bf-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-540-102020-01-31C16284748780-19d75b9d1-01bf-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-540-112020-01-31C16284748780-19d75b9d1-01bf-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP Rx only
65162-540-502020-01-31C16284748780-19d75b9d1-01bf-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-540-10Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10013
65162-540-11Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100013
65162-540-50Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-540CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 3 package rows20241027_390151d4-5fcb-46e2-92e6-de184827f43d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN390151d4-5fcb-46e2-92e6-de184827f43d13
828320cyclobenzaprine HCl 5 MG Oral TabletPSN390151d4-5fcb-46e2-92e6-de184827f43d13
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD390151d4-5fcb-46e2-92e6-de184827f43d13
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD390151d4-5fcb-46e2-92e6-de184827f43d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-540-1065162054010100 TABLET, FILM COATED in 1 BOTTLE (65162-540-10) 2010-02-180000-00-00NoNoCurrent
65162-540-11651620540111000 TABLET, FILM COATED in 1 BOTTLE (65162-540-11) 2010-02-180000-00-00NoNoCurrent
65162-540-5065162054050500 TABLET, FILM COATED in 1 BOTTLE (65162-540-50) 2010-02-180000-00-00NoNoCurrent