NDC 70518-0091
Kaletra
Lopinavir And Ritonavir
Kaletra is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Lopinavir; Ritonavir.
| Product ID | 70518-0091_8050ea56-b6aa-0e7a-e053-2a91aa0a3867 |
| NDC | 70518-0091 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Kaletra |
| Generic Name | Lopinavir And Ritonavir |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-12-29 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021906 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | LOPINAVIR; RITONAVIR |
| Active Ingredient Strength | 200 mg/1; mg/1 |
| Pharm 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 | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 70518-0091-2
30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0091-2)
| Marketing Start Date | 2017-02-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70518-0091-2 [70518009102]
Kaletra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021906 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-28 |
NDC 70518-0091-0 [70518009100]
Kaletra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021906 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-12-29 |
| Marketing End Date | 2020-04-19 |
NDC 70518-0091-1 [70518009101]
Kaletra TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021906 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-02-14 |
| Marketing End Date | 2020-04-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| LOPINAVIR | 200 mg/1 |
OpenFDA Data
| SPL SET ID: | f34556f4-b4a7-4b2e-9096-5c4557333271 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- 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 Crossover Matching brand name "Kaletra" or generic name "Lopinavir And Ritonavir"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0074-0522 | Kaletra | Lopinavir and Ritonavir |
| 0074-1575 | Kaletra | Lopinavir and Ritonavir |
| 0074-2605 | Kaletra | Lopinavir and Ritonavir |
| 0074-3956 | Kaletra | Lopinavir and Ritonavir |
| 0074-6799 | Kaletra | Lopinavir and Ritonavir |
| 11819-342 | Kaletra | Lopinavir and Ritonavir |
| 21695-362 | Kaletra | lopinavir and ritonavir |
| 53808-0276 | Kaletra | lopinavir and ritonavir |
| 55289-947 | Kaletra | Lopinavir and Ritonavir |
| 68258-1972 | Kaletra | Kaletra |
| 70518-0091 | Kaletra | Kaletra |
| 66336-624 | Kaletra | Kaletra |
| 68071-2348 | Kaletra | Kaletra |
| 31722-556 | Lopinavir and ritonavir | Lopinavir and ritonavir |
| 31722-603 | Lopinavir and ritonavir | Lopinavir and ritonavir |
| 42385-933 | Lopinavir and Ritonavir | Lopinavir and Ritonavir |
| 42385-934 | Lopinavir and Ritonavir | Lopinavir and Ritonavir |
Trademark Results [Kaletra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KALETRA 75465750 2451327 Live/Registered |
ABBVIE INC. 1998-04-09 |
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