NDC 68788-9508

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Cyclobenzaprine Hydrochloride.

Product ID68788-9508_20ed0ed9-8933-440d-a9d2-cee520ea9ff6
NDC68788-9508
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine Hydrochloride
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-02-26
Marketing CategoryANDA / ANDA
Application NumberANDA078048
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-9508-9

90 TABLET, FILM COATED in 1 BOTTLE (68788-9508-9)
Marketing Start Date2014-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9508-9 [68788950809]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-26
Marketing End Date2019-08-14

NDC 68788-9508-0 [68788950800]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-26
Marketing End Date2019-08-14

NDC 68788-9508-5 [68788950805]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-26
Marketing End Date2019-08-14

NDC 68788-9508-1 [68788950801]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-26
Marketing End Date2019-08-14

NDC 68788-9508-6 [68788950806]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-26
Marketing End Date2019-08-14

NDC 68788-9508-3 [68788950803]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-26
Marketing End Date2019-08-14

NDC 68788-9508-2 [68788950802]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-02-26
Marketing End Date2019-08-14

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:4325681e-859a-41c4-ace0-86d5ffd8008f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828320

    • 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
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