Kaletra
- Product NDC
- 0074-3956
- 11-digit product format
- 000743956
- Labeler code
- 0074
- Product ID
- 0074-3956_a0e519cd-694a-44de-9a89-eac59fce76c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lopinavir and Ritonavir
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- AbbVie Inc.
- Application
- NDA021251
- Marketing category
- NDA
- Marketing start
- 2010-06-18
- Substance
- LOPINAVIR; RITONAVIR
- Active strength
- 80; 20 mg/mL; mg/mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kaletra
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LOPINAVIR | 80 mg/mL |
| RITONAVIR | 20 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | O3J8G9O825, 2494G1JF75 |
| Rxcui | 311369, 597730, 746645, 847741, 847745, 847749 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1d2364f5-8b1e-7c9a-4518-7b359d95fa50 | Product name | 2 | 20250116 |
| 00d976a9-a12a-db3d-ac4e-27498af714cf | Product name | 5 | 20250115 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8d | Product name | 1 | 20231023 |
| c8f34825-48cd-e7db-4048-c3be840a9308 | Product name | 5 | 20230123 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| d1ee4fdb-1116-417b-8889-dc05571445b3 | Product name | 1 | 20160825 |
| f8d26468-b1dc-49d8-a188-8b5d531405ef | Product name | 1 | 20150731 |
| 0b1bb9d1-e628-4e7c-aada-fd6532257932 | Product name | 1 | 20150416 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 96979b26-bb9a-43d8-e3a6-d69b9e9f75e5 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0074-3956-46 | Kaletra | 160 mL in 1 BOTTLE | SOLUTION | 160 | 1700 | |
| 0074-3956-46 | Kaletra | 1 in 1 CARTON | SOLUTION | 1 | 1700 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0074-3956-46 | ML - Milliliter | 0074-3956 | acfd3478-1948-4297-98fe-ef8c21fec202 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0074-3956 | KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED KALETRA (LOPINAVIR AND RITONAVIR) SOLUTION [ABBVIE INC.] | 1700 | Current NDC, Legacy NDC, 2 package rows | 20240922_8290add3-4449-4e58-6c97-8fe1eec972e3.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 847745 | Kaletra 100 MG/ 25 MG Oral Tablet | PSN | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847741 | Kaletra 200 MG / 50 MG Oral Tablet | PSN | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847749 | Kaletra 80 MG / 20 MG in 1 mL Oral Solution | PSN | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 746645 | lopinavir 100 MG / ritonavir 25 MG Oral Tablet | PSN | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 597730 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet | PSN | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 311369 | lopinavir 80 MG / ritonavir 20 MG in 1 mL Oral Solution | PSN | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847745 | lopinavir 100 MG / ritonavir 25 MG Oral Tablet [Kaletra] | SBD | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847741 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra] | SBD | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847749 | lopinavir 80 MG/ML / ritonavir 20 MG/ML Oral Solution [Kaletra] | SBD | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 746645 | lopinavir 100 MG / ritonavir 25 MG Oral Tablet | SCD | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 597730 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet | SCD | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 311369 | lopinavir 80 MG/ML / ritonavir 20 MG/ML Oral Solution | SCD | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847745 | Kaletra 100 MG / 25 MG Oral Tablet | SY | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847741 | Kaletra 200 MG / 50 MG Oral Tablet | SY | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 847749 | Kaletra 80 MG / 20 MG per 1 ML Oral Solution | SY | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 311369 | lopinavir 400 MG / ritonavir 100 MG per 5 ML Oral Solution | SY | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
| 311369 | lopinavir 80 MG / ritonavir 20 MG per 1 ML Oral Solution | SY | 8290add3-4449-4e58-6c97-8fe1eec972e3 | 1700 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0074-3956-46 | 00074395646 | 1 BOTTLE in 1 CARTON (0074-3956-46) / 160 mL in 1 BOTTLE | 1 bottle | 2010-06-18 | 0000-00-00 | No | No | Current |