NDC 69336-104

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride is a Oral Capsule, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sterling Knight Pharmaceuticals,llc. The primary component is Cyclobenzaprine Hydrochloride.

Product ID69336-104_e49e22dc-5660-4d54-8a62-d0e04a7f1a99
NDC69336-104
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine Hydrochloride
Generic NameCyclobenzaprine Hydrochloride
Dosage FormCapsule, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-11-03
Marketing CategoryANDA / ANDA
Application NumberANDA078218
Labeler NameSterling Knight Pharmaceuticals,LLC
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69336-104-50

500 CAPSULE, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69336-104-50)
Marketing Start Date2016-11-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69336-104-11 [69336010411]

Cyclobenzaprine Hydrochloride CAPSULE, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-04
Inactivation Date2020-01-31

NDC 69336-104-10 [69336010410]

Cyclobenzaprine Hydrochloride CAPSULE, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-04
Inactivation Date2020-01-31

NDC 69336-104-50 [69336010450]

Cyclobenzaprine Hydrochloride CAPSULE, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:9312079f-4bef-4d2a-ba8a-62c94145a4e5
Manufacturer
UNII
UPC Code
  • 0369336104111
  • 0369336105118

    • Pharmacological Class

    • Centrally-mediated Muscle Relaxation [PE]
    • Muscle Relaxant [EPC]

    NDC Crossover Matching brand name "Cyclobenzaprine Hydrochloride" or generic name "Cyclobenzaprine Hydrochloride"

    NDCBrand NameGeneric Name
    0093-1920Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-1921Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-3420Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-3421Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-3422Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0115-1436Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0115-1437Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0179-0057cyclobenzaprine hydrochloridecyclobenzaprine hydrochloride
    0179-0189cyclobenzaprine hydrochloridecyclobenzaprine hydrochloride
    0378-0751Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0378-0761Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0378-0771Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0440-1350Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0440-7350Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0591-3256Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0591-3330Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0591-5658Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0615-3520Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0615-7528Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0615-8084Cyclobenzaprine HydrochlorideCyclobenzaprine
    0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3149Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-1983Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-1961Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-1998Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3154Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3377Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3150Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3390Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-4076Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-4415Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride
    68071-4502Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-4655CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE
    68071-4826Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68084-753Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68258-7150CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE
    68258-7013Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68387-500Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68387-502Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68645-518Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68645-517Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-6375Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-7398Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9069Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-7131Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9508Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9295Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9967Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    69097-846Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    69097-845Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.