Lopinavir and Ritonavir

Product NDC

69097-561

11-digit product format

690970561

Labeler code

69097

Product ID

69097-561_10c9b9cf-8b34-4a34-8259-c01b80ad2d31

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Lopinavir and Ritonavir

Dosage form

TABLET

Route

ORAL

Labeler

Cipla USA Inc.

Application

ANDA090371

Marketing category

ANDA

Marketing start

2020-06-26

Marketing end

0000-00-00

Substance

LOPINAVIR; RITONAVIR

Active strength

100 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

2021-12-31

Current FDA listing

Historical FDA.report record