Prescription drug · NDA
Kaletra (Lopinavir and ritonavir) NDC 0074-4014
Lopinavir 200 mg/1; Ritonavir 50 mg/1 · Tablet, Film coated · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-4014-12 | 00074401412 | 120 TABLET, FILM COATED in 1 BOTTLE (0074-4014-12)Marketed from Feb 15, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Kaletra
- Generic name (nonproprietary)
- lopinavir and ritonavir
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021906
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)UDP Glucuronosyltransferases Inducers (Mechanism)
- Identifiers
- Product ID 0074-4014_36abdfba-ddc2-43ae-9173-903d66a23b23SPL ID 36abdfba-ddc2-43ae-9173-903d66a23b23SPL set ID 8290add3-4449-4e58-6c97-8fe1eec972e3RxCUI 311369, 597730, 746645, 847741, 847745, 847749UNII O3J8G9O825, 2494G1JF75
- Pharmacologic class
- Cytochrome P450 3A Inhibitor; Protease Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400074401412followed by a unit qualifier and the quantityPackage 00074-4014-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology ( 12.4 )] . KALETRA is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0074-4014
- What is NDC 0074-4014?
- 0074-4014 is the product NDC for Kaletra, Lopinavir 200 mg/1; Ritonavir 50 mg/1 tablet, film coated, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kaletra (Lopinavir and Ritonavir).
- What is the active ingredient?
- Lopinavir, Ritonavir.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kaletra?
- 2 other product NDCs are listed under this name. See all Kaletra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kaletra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kaletralopinavir and ritonavir | Lopinavir 100 mg/1; Ritonavir 25 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-3008 | 00074-3008-60 |
| Kaletralopinavir and ritonavir | Lopinavir 80 mg/mL; Ritonavir 20 mg/mL | SolutionOral | AbbVie Inc. | 0074-3956 | 00074-3956-46 |
Other NDCs under NDA 021906
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Kaletralopinavir and ritonavir | Lopinavir 100 mg/1; Ritonavir 25 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-3008 |