NDC 21695-362

Kaletra

Lopinavir And Ritonavir

Kaletra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Lopinavir; Ritonavir.

• Product ID: 21695-362_20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c
• NDC: 21695-362
• Product Type: Human Prescription Drug
• Proprietary Name: Kaletra
• Generic Name: Lopinavir And Ritonavir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2010-06-18
• Marketing Category: NDA / NDA
• Application Number: NDA021906
• Labeler Name: Rebel Distributors Corp
• Substance Name: LOPINAVIR; RITONAVIR
• Active Ingredient Strength: 200 mg/1; mg/1
• Pharm Classes: HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-362-12

12 TABLET, FILM COATED in 1 BOTTLE (21695-362-12)

• Marketing Start Date: 2010-06-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-362-12 [21695036212]

Kaletra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021906
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-06-18
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
LOPINAVIR	200 mg/1

OpenFDA Data

• SPL SET ID: 20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 2494G1JF75
  • O3J8G9O825
• RxNorm Concept Unique ID - RxCUI:
  • 847741
  • 597730

Pharmacological Class

• HIV Protease Inhibitors [MoA]
• Cytochrome P450 3A Inhibitor [EPC]
• Protease Inhibitor [EPC]
• Cytochrome P450 3A Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Cytochrome P450 2C19 Inducers [MoA]
• Cytochrome P450 3A Inducers [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]
• Cytochrome P450 1A2 Inducers [MoA]
• Cytochrome P450 2C9 Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• UDP Glucuronosyltransferases Inducers [MoA]
• HIV Protease Inhibitors [MoA]
• Protease Inhibitor [EPC]
• P-Glycoprotein Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]

NDC Crossover Matching brand name "Kaletra" or generic name "Lopinavir And Ritonavir"

NDC	Brand Name	Generic Name
0074-0522	Kaletra	Lopinavir and Ritonavir
0074-1575	Kaletra	Lopinavir and Ritonavir
0074-2605	Kaletra	Lopinavir and Ritonavir
0074-3956	Kaletra	Lopinavir and Ritonavir
0074-6799	Kaletra	Lopinavir and Ritonavir
11819-342	Kaletra	Lopinavir and Ritonavir
21695-362	Kaletra	lopinavir and ritonavir
53808-0276	Kaletra	lopinavir and ritonavir
55289-947	Kaletra	Lopinavir and Ritonavir
68258-1972	Kaletra	Kaletra
70518-0091	Kaletra	Kaletra
66336-624	Kaletra	Kaletra
68071-2348	Kaletra	Kaletra
31722-556	Lopinavir and ritonavir	Lopinavir and ritonavir
31722-603	Lopinavir and ritonavir	Lopinavir and ritonavir
42385-933	Lopinavir and Ritonavir	Lopinavir and Ritonavir
42385-934	Lopinavir and Ritonavir	Lopinavir and Ritonavir