Kaletra
- Product NDC
- 0074-2605
- 11-digit product format
- 000742605
- Labeler code
- 0074
- Product ID
- 0074-2605_0195c057-8795-448e-b1e4-c168d23e4301
- 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
- Marketing end
- 0000-00-00
- Substance
- LOPINAVIR; RITONAVIR
- Active strength
- 200 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 0074-2605-21 | Kaletra | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 1700 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0074-2605-21 | EA - Each | 0074-2605 | f5efdb6c-f679-4a0f-ad02-a7245ee4edf7 | 1 | 2020-05-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0074-2605-21 | 00074260521 | 120 TABLET, FILM COATED in 1 BOTTLE (0074-2605-21) | 2020-04-08 | 0000-00-00 | No | No | Current |