Kaletra

Product NDC

55289-947

11-digit product format

552890947

Labeler code

55289

Product ID

55289-947_d2946a2b-6f39-6c2b-e053-2995a90a65d6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lopinavir and Ritonavir

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

NDA021906

Marketing category

NDA

Marketing start

2010-06-18

Marketing end

0000-00-00

Substance

LOPINAVIR; RITONAVIR

Active strength

200 mg/1; mg/1

Pharmacologic classes

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 exclude flag

No

Listing certified through

2022-12-31

Current FDA listing

Historical FDA.report record