NDC 68151-5004

Ranexa

Ranolazine

Ranexa is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Ranolazine.

• Product ID: 68151-5004_892444ae-b9ca-4022-bcd3-f676848f83e8
• NDC: 68151-5004
• Product Type: Human Prescription Drug
• Proprietary Name: Ranexa
• Generic Name: Ranolazine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2006-01-27
• Marketing Category: NDA / NDA
• Application Number: NDA021526
• Labeler Name: Carilion Materials Management
• Substance Name: RANOLAZINE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 68151-5004-1

1 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (68151-5004-1)

• Marketing Start Date: 2006-01-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68151-5004-1 [68151500401]

Ranexa TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021526
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-01-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RANOLAZINE	500 mg/1

OpenFDA Data

• SPL SET ID: e038f963-d78f-460e-a11f-46f224061505
• Manufacturer:
  • Carilion Materials Management
• UNII:
  • A6IEZ5M406
• RxNorm Concept Unique ID - RxCUI:
  • 616749
  • 860738

Pharmacological Class

• Anti-anginal [EPC]
• Cytochrome P450 3A Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Organic Cation Transporter 2 Inhibitors [MoA]

NDC Crossover Matching brand name "Ranexa" or generic name "Ranolazine"

NDC	Brand Name	Generic Name
43353-880	Ranexa	RANOLAZINE
68151-5004	Ranexa	Ranexa
61958-1003	Ranexa	Ranexa
61958-1001	Ranexa	Ranexa
61958-1004	Ranexa	Ranexa
61958-1002	Ranexa	Ranexa
47335-624	ASPRUZYO SPRINKLE	Ranolazine
47335-625	ASPRUZYO SPRINKLE	Ranolazine
27241-125	Ranolazine	Ranolazine
27241-126	Ranolazine	Ranolazine
31722-668	Ranolazine	Ranolazine
31722-669	Ranolazine	Ranolazine
42291-773	Ranolazine	RANOLAZINE
42291-774	Ranolazine	RANOLAZINE
42385-963	Ranolazine	Ranolazine
42385-964	Ranolazine	Ranolazine
42571-324	Ranolazine	Ranolazine
42571-325	Ranolazine	Ranolazine
43975-289	Ranolazine	Ranolazine
43975-290	Ranolazine	Ranolazine
45963-418	Ranolazine	Ranolazine
45963-419	Ranolazine	Ranolazine
48792-7893	RANOLAZINE	ranolazine
48792-7894	RANOLAZINE	ranolazine
50228-423	RANOLAZINE	RANOLAZINE
50228-424	RANOLAZINE	RANOLAZINE
50268-722	Ranolazine	Ranolazine