NDC 69584-149

Cyclobenzaprine HCl

Cyclobenzaprine Hcl

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

Product ID69584-149_d87716a8-936d-4319-b54f-f36e1e103037
NDC69584-149
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine HCl
Generic NameCyclobenzaprine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-01-25
Marketing CategoryANDA / ANDA
Application NumberANDA077209
Labeler NameOxford Pharmaceuticals, LLC
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69584-149-90

1000 TABLET, FILM COATED in 1 BOTTLE (69584-149-90)
Marketing Start Date2018-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69584-149-10 [69584014910]

Cyclobenzaprine HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077209
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-11-14

NDC 69584-149-90 [69584014990]

Cyclobenzaprine HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077209
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-11-14

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:591a63a0-c1c1-4112-8b65-502dc4bf6fea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828348
  • 828320
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Cyclobenzaprine HCl" or generic name "Cyclobenzaprine Hcl"

    NDCBrand NameGeneric Name
    61919-901CYCLOBENZAPRINE HCLPrilosec 40mg Tabs
    69584-148Cyclobenzaprine HClCyclobenzaprine HCl
    69584-149Cyclobenzaprine HClCyclobenzaprine HCl
    80425-0015Cyclobenzaprine HCLCyclobenzaprine HCL
    80425-0016Cyclobenzaprine HCLCyclobenzaprine HCL
    80425-0017Cyclobenzaprine HCLCyclobenzaprine HCL
    80425-0018Cyclobenzaprine HCLCyclobenzaprine HCL
    80425-0078Cyclobenzaprine HCLCyclobenzaprine HCL
    80425-0155Cyclobenzaprine HCLCyclobenzaprine HCL

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