Kaletra
- Product NDC
- 53808-0276
- 11-digit product format
- 538080276
- Labeler code
- 53808
- Product ID
- 53808-0276_b4e1380c-7e64-4455-a71f-080954122c0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lopinavir and ritonavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DOH CENTRAL PHARMACY
- Application
- NDA021906
- Marketing category
- NDA
- Marketing start
- 2009-07-01
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 53808-0276-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9cd6-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir/ritonavir) tablets, 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 |
|---|---|---|---|---|---|---|
| 53808-0276-1 | Kaletra | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0276 | KALETRA (LOPINAVIR AND RITONAVIR) TABLET, FILM COATED [DOH CENTRAL PHARMACY] | 3 | Legacy NDC, 1 package rows | 20170206_c7fc2d1e-802e-4da1-9763-3355f8aafe3a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 847741 | Kaletra 200 MG / 50 MG Oral Tablet | PSN | c7fc2d1e-802e-4da1-9763-3355f8aafe3a | 3 |
| 597730 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet | PSN | c7fc2d1e-802e-4da1-9763-3355f8aafe3a | 3 |
| 847741 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet [Kaletra] | SBD | c7fc2d1e-802e-4da1-9763-3355f8aafe3a | 3 |
| 597730 | lopinavir 200 MG / ritonavir 50 MG Oral Tablet | SCD | c7fc2d1e-802e-4da1-9763-3355f8aafe3a | 3 |
| 847741 | Kaletra 200 MG / 50 MG Oral Tablet | SY | c7fc2d1e-802e-4da1-9763-3355f8aafe3a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0276-1 | 53808027601 | 30 in 1 BLISTER PACK | Historical |