NDC 61919-065

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: 61919-065_98767496-5afa-4b76-ae21-3f5dbd703fed
• NDC: 61919-065
• Product Type: Human Prescription Drug
• Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
• Generic Name: Cyclobenzaprine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-01
• 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 61919-065-15

15 TABLET in 1 BOTTLE (61919-065-15)

• Marketing Start Date: 2015-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-065-20 [61919006520]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-01
• Inactivation Date: 2020-01-31

NDC 61919-065-72 [61919006572]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-01
• Inactivation Date: 2020-01-31

NDC 61919-065-30 [61919006530]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-01

NDC 61919-065-60 [61919006560]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-01
• Inactivation Date: 2020-01-31

NDC 61919-065-90 [61919006590]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-01

NDC 61919-065-15 [61919006515]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET

• Marketing Category: ANDA
• Application Number: ANDA090478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 5f2c5599-c4cd-47d6-83bb-a7cc1cf70db7
• 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