FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
59746-177
11-digit product format
597460177
Labeler code
59746
Product ID
59746-177_a18ba005-b6de-4c5b-a837-489d74022084
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299, 828320, 828348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-177-06Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
59746-177-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-177-06EA - Each59746-17762cf2fa8-752e-4cf4-b3ef-0c7de278c25812012-07-24
59746-177-10EA - Each59746-177ba04cb0b-4a0c-40e1-997d-75e4a9d556a412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cyclobenzaprine hydrochlorideACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
cyclobenzaprineACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
lactoseINACTIVE INGREDIENTJ2B2A4N98GCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
talcINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
cyclobenzaprine hydrochlorideACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
cyclobenzaprineACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-177CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20250227_592871f6-0eb2-4624-9e10-bd8bf767c002.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN592871f6-0eb2-4624-9e10-bd8bf767c0026
828320cyclobenzaprine HCl 5 MG Oral TabletPSN592871f6-0eb2-4624-9e10-bd8bf767c0026
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN592871f6-0eb2-4624-9e10-bd8bf767c0026
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD592871f6-0eb2-4624-9e10-bd8bf767c0026
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD592871f6-0eb2-4624-9e10-bd8bf767c0026
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD592871f6-0eb2-4624-9e10-bd8bf767c0026
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb8ee8ddd-44ff-4149-9969-519fef14938a4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb8ee8ddd-44ff-4149-9969-519fef14938a4
828348cyclobenzaprine HCl 10 MG Oral TabletPSNa264ab9f-cc12-325f-e053-2a95a90a53d93
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb336d6ef-8f76-6225-e053-2a95a90a8f333
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb336d6ef-8f76-6225-e053-2a95a90a8f333
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDa264ab9f-cc12-325f-e053-2a95a90a53d93
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdb90bdea-e099-4a94-b6d2-f3fe98eb03922
828348cyclobenzaprine HCl 10 MG Oral TabletPSN0b9e0dc5-79f5-4ff6-99ca-33ecbda0bb522
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdb90bdea-e099-4a94-b6d2-f3fe98eb03922
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD0b9e0dc5-79f5-4ff6-99ca-33ecbda0bb522
828348cyclobenzaprine HCl 10 MG Oral TabletPSNe9063c42-e71a-4cce-9cd9-9ed6a192c6bb1
828348cyclobenzaprine HCl 10 MG Oral TabletPSN9b4d726d-391e-4fbe-9958-baf8c638ec8f1
828348cyclobenzaprine HCl 10 MG Oral TabletPSN879a4e55-012d-4988-b571-9a8cf94414dd1
828348cyclobenzaprine HCl 10 MG Oral TabletPSN47d22c6d-49fb-f97c-e063-6294a90a6ba11
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD9b4d726d-391e-4fbe-9958-baf8c638ec8f1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD879a4e55-012d-4988-b571-9a8cf94414dd1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDe9063c42-e71a-4cce-9cd9-9ed6a192c6bb1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD47d22c6d-49fb-f97c-e063-6294a90a6ba11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-177-0659746017706100 TABLET, FILM COATED in 1 BOTTLE (59746-177-06) 2006-04-040000-00-00NoNoCurrent
59746-177-10597460177101000 TABLET, FILM COATED in 1 BOTTLE (59746-177-10) 2006-04-040000-00-00NoNoCurrent