NDC 55289-947

Kaletra

Lopinavir And Ritonavir

Kaletra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Lopinavir; Rito.

• Product ID: 55289-947_7bbc98d2-b485-7999-e053-2991aa0a2b68
• NDC: 55289-947
• 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: PD-Rx Pharmaceuticals, In
• Substance Name: LOPINAVIR; RITO
• Active Ingredient Strength: 200 mg/1; mg/1
• Pharm Classes: HIV Protease In
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-947-12

12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-947-12)

• Marketing Start Date: 2011-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-947-12 [55289094712]

Kaletra TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021906
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-03-03

Drug Details

Active Ingredients

Ingredient	Strength
LOPINAVIR	200 mg/1

OpenFDA Data

• SPL SET ID: e2f854cb-7f91-4269-ba67-97065ac8b4a0
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 2494G1JF75
  • O3J8G9O825
• RxNorm Concept Unique ID - RxCUI:
  • 847741
  • 597730
• UPC Code:
  • 0355289947127

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