NDC 0074-3956

Kaletra

Lopinavir And Ritonavir

Kaletra is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Lopinavir; Ritonavir.

• Product ID: 0074-3956_0195c057-8795-448e-b1e4-c168d23e4301
• NDC: 0074-3956
• Product Type: Human Prescription Drug
• Proprietary Name: Kaletra
• Generic Name: Lopinavir And Ritonavir
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2010-06-18
• Marketing Category: NDA / NDA
• Application Number: NDA021251
• Labeler Name: AbbVie Inc.
• Substance Name: LOPINAVIR; RITONAVIR
• Active Ingredient Strength: 80 mg/mL; mg/mL
• Pharm Classes: Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0074-3956-46

1 BOTTLE in 1 CARTON (0074-3956-46) > 160 mL in 1 BOTTLE

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

NDC SPL Data Element Entries

NDC 0074-3956-46 [00074395646]

Kaletra SOLUTION

• Marketing Category: NDA
• Application Number: NDA021251
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-06-18

Drug Details

Active Ingredients

Ingredient	Strength
LOPINAVIR	80 mg/mL

OpenFDA Data

• SPL SET ID: 8290add3-4449-4e58-6c97-8fe1eec972e3
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • 2494G1JF75
  • O3J8G9O825
• RxNorm Concept Unique ID - RxCUI:
  • 597730
  • 746645
  • 847749
  • 847745
  • 847741
  • 311369
• UPC Code:
  • 0300740522603
  • 0300746799221

Pharmacological Class

• HIV Protease Inhibitors [MoA]
• Protease Inhibitor [EPC]
• P-Glycoprotein Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• 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]

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