FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
59746-211
11-digit product format
597460211
Labeler code
59746
Product ID
59746-211_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
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
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
59746-211-06Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
59746-211-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-211-06EA - Each59746-211cf995554-7988-4f5a-9adb-b96a31e1215e12012-07-24
59746-211-10EA - Each59746-211b2c656ef-252b-41d6-a6ef-958f9fb0f91f12012-07-24

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 [REBEL DISTRIBUTORS]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-211CYCLOBENZAPRINE 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
828320cyclobenzaprine HCl 5 MG Oral TabletPSNdcef9b63-f998-4852-920d-c356623cea6a103
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDdcef9b63-f998-4852-920d-c356623cea6a103
828320cyclobenzaprine HCl 5 MG Oral TabletPSN3f1b9c8a-8f75-4b84-af0c-739815937fd7101
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD3f1b9c8a-8f75-4b84-af0c-739815937fd7101
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
828320cyclobenzaprine HCl 5 MG Oral TabletPSNafca2a49-6424-7b6a-e053-2a95a90ad41e5
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDafca2a49-6424-7b6a-e053-2a95a90ad41e5
828320cyclobenzaprine HCl 5 MG Oral TabletPSNba142223-1c8b-4ea6-b531-37f7b2dddf664
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDba142223-1c8b-4ea6-b531-37f7b2dddf664
828320cyclobenzaprine HCl 5 MG Oral TabletPSN1d76a397-2aec-4614-9b54-059857cfe4d82
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD1d76a397-2aec-4614-9b54-059857cfe4d82
828320cyclobenzaprine HCl 5 MG Oral TabletPSNdd2d3cf8-293c-4c3b-bdce-81f5c6a220ef1
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDdd2d3cf8-293c-4c3b-bdce-81f5c6a220ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-211-0659746021106100 TABLET, FILM COATED in 1 BOTTLE (59746-211-06) 2006-04-040000-00-00NoNoCurrent
59746-211-10597460211101000 TABLET, FILM COATED in 1 BOTTLE (59746-211-10) 2006-04-040000-00-00NoNoCurrent