NDC 43063-516

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride

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

Product ID43063-516_81b9e40a-cea3-4e2f-e053-2a91aa0a057a
NDC43063-516
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine Hydrochloride
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA078048
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-516-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-01)
Marketing Start Date2018-12-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-516-42 [43063051642]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-17

NDC 43063-516-60 [43063051660]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-19

NDC 43063-516-95 [43063051695]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 43063-516-03 [43063051603]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-12 [43063051612]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-27

NDC 43063-516-82 [43063051682]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 43063-516-09 [43063051609]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-15

NDC 43063-516-01 [43063051601]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 43063-516-90 [43063051690]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-08-08

NDC 43063-516-30 [43063051630]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-21 [43063051621]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-14 [43063051614]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-15 [43063051615]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-20 [43063051620]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-10 [43063051610]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-04 [43063051604]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

NDC 43063-516-40 [43063051640]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-06

NDC 43063-516-06 [43063051606]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-07-31

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:72031488-c339-48e1-8299-db7e5ad0c6f3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828348
    • UPC Code
  • 0343063516010

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.