NDC 61919-901

CYCLOBENZAPRINE HCL

Prilosec 40mg Tabs

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

• Product ID: 61919-901_85b93754-7c21-26d6-e053-2991aa0a724a
• NDC: 61919-901
• Product Type: Human Prescription Drug
• Proprietary Name: CYCLOBENZAPRINE HCL
• Generic Name: Prilosec 40mg Tabs
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077797
• Labeler Name: DIRECTRX
• 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: 2020-12-31

Packaging

NDC 61919-901-30

30 TABLET, FILM COATED in 1 BOTTLE (61919-901-30)

• Marketing Start Date: 2019-04-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-901-15 [61919090115]

CYCLOBENZAPRINE HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077797
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-09-30

NDC 61919-901-90 [61919090190]

CYCLOBENZAPRINE HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077797
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-09-30

NDC 61919-901-60 [61919090160]

CYCLOBENZAPRINE HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077797
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-09-30

NDC 61919-901-30 [61919090130]

CYCLOBENZAPRINE HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077797
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-04

NDC 61919-901-20 [61919090120]

CYCLOBENZAPRINE HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077797
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-15

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 858d10e7-dfe5-4c4f-e053-2a91aa0a783e
• Manufacturer:
  • DIRECTRX
• UNII:
  • 0VE05JYS2P
• RxNorm Concept Unique ID - RxCUI:
  • 828299
  • 828320

Pharmacological Class

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

NDC Crossover Matching brand name "CYCLOBENZAPRINE HCL" or generic name "Prilosec 40mg Tabs"

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