Kaletra
- Product NDC
- 0074-4014
- 11-digit product format
- 000744014
- Labeler code
- 0074
- Product ID
- 0074-4014_a0e519cd-694a-44de-9a89-eac59fce76c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lopinavir and Ritonavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AbbVie Inc.
- Application
- NDA021906
- Marketing category
- NDA
- Marketing start
- 2020-04-08
- Substance
- LOPINAVIR; RITONAVIR
- Active strength
- 200; 50 mg/1; mg/1
- Pharmacologic 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
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2494G1JF75 | LOPINAVIR | 192725-17-0 | LOPINAVIR |
| O3J8G9O825 | RITONAVIR | 155213-67-5 | RITONAVIR |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0074-4014-12 | 00074401412 | 120 TABLET, FILM COATED in 1 BOTTLE (0074-4014-12) | 2024-02-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Kaletra | AbbVie Inc. | 2023-04-01 | HUMAN PRESCRIPTION DRUG LABEL | 1700 |