Kaletra
- Product NDC
- 66336-624
- 11-digit product format
- 663360624
- Labeler code
- 66336
- Product ID
- 66336-624_8e2fad31-7e6d-426c-b2f4-487d870f2374
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lopinavir and Ritonavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dispensing Solutions, 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
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66336-624-12 | 2019-11-27 | C162847 | 48780-1 | 9855d018-eb61-cd31-e053-dbdaa90ab51a | These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir/ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir/ritonavir) Solution for Oral use Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66336-624-12 | Kaletra | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 847741 | Kaletra 200 MG / 50 MG Oral Tablet | PSN | dac2ea61-f5ce-45b8-b4aa-d761c5aecd74 | 1 |
| 597730 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet | PSN | dac2ea61-f5ce-45b8-b4aa-d761c5aecd74 | 1 |
| 847741 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra] | SBD | dac2ea61-f5ce-45b8-b4aa-d761c5aecd74 | 1 |
| 597730 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet | SCD | dac2ea61-f5ce-45b8-b4aa-d761c5aecd74 | 1 |
| 847741 | Kaletra 200 MG / 50 MG Oral Tablet | SY | dac2ea61-f5ce-45b8-b4aa-d761c5aecd74 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 66336-624-12 | 66336062412 | 12 in 1 BOTTLE | Historical |