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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077563-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19
A077563-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19
A077563-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A077563-001AB
A077563-002AB
A077563-003AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.592871f6-0eb2-4624-9e10-bd8bf767c0022025-02-21Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of cyclobenzaprine hydrochloride with MAO inhibitors is contraindicated (see CONTRAINDICATIONS ). Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Treatment with cyclobenzaprine hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated. If concomitant treatment with cyclobenzaprine hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see PRECAUTIONS : Drug Interactions ). Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS , below, and ADVERSE REACTIONS ). Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. Cyclobenzaprine may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Incidence of most common adverse reactions in the two double-blind*, placebo-controlled 5 mg studies (incidence of >3% on cyclobenzaprine hydrochloride 5 mg): Cyclobenzaprine Hydrochloride 5 mg N=464 Cyclobenzaprine Hydrochloride 10 mg N=249 Placebo N=469 Drowsiness 29% 38% 10% Dry Mouth 21% 32% 7% Fatigue 6% 6% 3% Headache 5% 5% 8% *Note: Cyclobenzaprine hydrochloride 10 mg data are from one clinical trial. Cyclobenzaprine hydrochloride 5 mg and placebo data are from two studies. Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis. The following list of adverse reactions is based on the experience in 473 patients treated with cyclobenzaprine hydrochloride 10 mg in additional controlled clinical studies, 7,607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies. The adverse reactions reported most frequently with cyclobenzaprine were drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies: Clinical Studies with Cyclobenzaprine Hydrochloride 10 mg Surveillance Program with Cyclobenzaprine Hydrochloride 10 mg Drowsiness 39% 16% Dry Mouth 27% 7% Dizziness 11% 3% Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion. The following adverse reactions have been reported in postmarketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet: Body as a Whole: Syncope; malaise. Cardiovascular: Tachycardia; arrhythmia; vasodilatation; palpitation; hypotension. Digestive: Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare rep...

adverse reactions table

Cyclobenzaprine Hydrochloride 5 mg N=464 Cyclobenzaprine Hydrochloride 10 mg N=249 Placebo N=469Drowsiness 29% 38% 10%Dry Mouth 21% 32% 7%Fatigue6% 6% 3%Headache5% 5% 8%

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 (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
cyclobenzaprineACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
talcINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [KAISER FOUNDATION HOSPITALS]2
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