Lopinavir-ritonavir
NDC Package 0527-1947-48
Package Information
Lopinavir-ritonavir is this combination product contains two medications: lopinavir and ritonavir. Marketed by Lannett Company, Inc., this product is identified by NDC 0527-1947 and is authorized under FDA application ANDA207407.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0527 - Lannett Company, Inc.
- 0527-1947 - Lopinavir-ritonavir
- 0527-1947-48 - 1 BOTTLE, PLASTIC in 1 CARTON / 160 mL in 1 BOTTLE, PLASTIC
- 0527-1947 - Lopinavir-ritonavir
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0527-1947-48 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 160 ml in 1 bottle, plastic of Lopinavir-ritonavir, labeled by Lannett Company, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lannett Company, Inc. on December 27, 2016. The current certification is valid through April 30, 2025.
What are the primary indications for this medication?
This combination product contains two medications: lopinavir and ritonavir. This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Both lopinavir and ritonavir belong to a class of drugs known as HIV protease inhibitors. Ritonavir increases ("boosts") the levels of lopinavir. This helps lopinavir work better. Because this solution contains other ingredients (alcohol and propylene glycol) that may cause side effects, it is not recommended for premature (pre-term) newborns right after birth or full-term newborns younger than 14 days of age, unless your doctor thinks it is right for your baby. Discuss the risks and benefits with your doctor. Lopinavir/ritonavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
How is this Lannett Company, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00527194748. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.