FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
59746-735
11-digit product format
597460735
Labeler code
59746
Product ID
59746-735_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
2017-10-09
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 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
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-735-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
59746-735-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006
59746-735-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-735-01EA - Each59746-735b7acb35e-1ec7-4dd1-94b4-efade322cade12018-01-12

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-735CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 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
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNf77a095a-92b6-4809-952e-4feee415a5fc4
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDf77a095a-92b6-4809-952e-4feee415a5fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-735-0159746073501100 TABLET, FILM COATED in 1 BOTTLE (59746-735-01) 2017-10-090000-00-00NoNoCurrent
59746-735-10597460735101000 TABLET, FILM COATED in 1 BOTTLE (59746-735-10) 2017-10-090000-00-00NoNoCurrent
59746-735-305974607353030 TABLET, FILM COATED in 1 BOTTLE (59746-735-30) 2017-10-090000-00-00NoNoCurrent