NDC 61919-064

CYCLOBENZAPRINE HYDROCHLORIDE

Cyclobenzaprine Hydrochloride

CYCLOBENZAPRINE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Cyclobenzaprine Hydrochloride.

• Product ID: 61919-064_41715d9f-35a6-0708-e054-00144ff8d46c
• NDC: 61919-064
• Product Type: Human Prescription Drug
• Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
• Generic Name: Cyclobenzaprine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-11-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090478
• Labeler Name: DIRECT RX
• Substance Name: CYCLOBENZAPRINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-064-20

20 TABLET, FILM COATED in 1 BOTTLE (61919-064-20)

• Marketing Start Date: 2016-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-064-60 [61919006460]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-16

NDC 61919-064-30 [61919006430]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-16

NDC 61919-064-90 [61919006490]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-16

NDC 61919-064-20 [61919006420]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-16

NDC 61919-064-72 [61919006472]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-16

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 41709710-5397-3119-e054-00144ff88e88
• Manufacturer:
  • DIRECT RX
• UNII:
  • 0VE05JYS2P
• RxNorm Concept Unique ID - RxCUI:
  • 828348

Pharmacological Class

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

NDC Crossover Matching brand name "CYCLOBENZAPRINE HYDROCHLORIDE" or generic name "Cyclobenzaprine Hydrochloride"

NDC	Brand Name	Generic Name
0093-1920	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0093-1921	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0093-3420	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0093-3421	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0093-3422	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0115-1436	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0115-1437	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0179-0057	cyclobenzaprine hydrochloride	cyclobenzaprine hydrochloride
0179-0189	cyclobenzaprine hydrochloride	cyclobenzaprine hydrochloride
0378-0751	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride
0378-0761	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride
0378-0771	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride
0440-1350	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0440-7350	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0591-3256	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0591-3330	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0591-5658	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
0615-3520	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride
0615-7528	Cyclobenzaprine Hydrochloride	cyclobenzaprine hydrochloride
0615-8084	Cyclobenzaprine Hydrochloride	Cyclobenzaprine
0615-8182	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-3149	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-1983	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-1961	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-1998	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-3154	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-3377	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-3150	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-3390	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-4076	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-4415	Cyclobenzaprine hydrochloride	Cyclobenzaprine hydrochloride
68071-4502	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68071-4655	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE
68071-4826	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68084-753	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68258-7150	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE
68258-7013	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68387-500	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68387-502	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68645-518	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68645-517	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68788-6375	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68788-7398	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68788-9069	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68788-7131	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68788-9508	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68788-9295	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
68788-9967	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
69097-846	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride
69097-845	Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride