NDC 69584-148

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 ID: 69584-148_d87716a8-936d-4319-b54f-f36e1e103037
• NDC: 69584-148
• Product Type: Human Prescription Drug
• Proprietary Name: Cyclobenzaprine HCl
• Generic Name: Cyclobenzaprine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-01-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077209
• Labeler Name: Oxford Pharmaceuticals, LLC
• Substance Name: CYCLOBENZAPRINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69584-148-10

100 TABLET, FILM COATED in 1 BOTTLE (69584-148-10)

• Marketing Start Date: 2018-01-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69584-148-90 [69584014890]

Cyclobenzaprine HCl TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077209
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-25
• Marketing End Date: 2019-11-14

NDC 69584-148-10 [69584014810]

Cyclobenzaprine HCl TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077209
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-25
• Marketing End Date: 2019-11-14

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 591a63a0-c1c1-4112-8b65-502dc4bf6fea
• Manufacturer:
  • Oxford Pharmaceuticals, LLC
• UNII:
  • 0VE05JYS2P
• 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"

NDC	Brand Name	Generic Name
61919-901	CYCLOBENZAPRINE HCL	Prilosec 40mg Tabs
69584-148	Cyclobenzaprine HCl	Cyclobenzaprine HCl
69584-149	Cyclobenzaprine HCl	Cyclobenzaprine HCl
80425-0015	Cyclobenzaprine HCL	Cyclobenzaprine HCL
80425-0016	Cyclobenzaprine HCL	Cyclobenzaprine HCL
80425-0017	Cyclobenzaprine HCL	Cyclobenzaprine HCL
80425-0018	Cyclobenzaprine HCL	Cyclobenzaprine HCL
80425-0078	Cyclobenzaprine HCL	Cyclobenzaprine HCL
80425-0155	Cyclobenzaprine HCL	Cyclobenzaprine HCL