Prescription drug · ANDA
Lopinavir and ritonavir NDC 31722-556
Lopinavir 200 mg/1; Ritonavir 50 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-556-12 | 31722055612 | 120 TABLET, FILM COATED in 1 BOTTLE (31722-556-12)Marketed from Jun 7, 2021 | |
| 31722-556-31 | 31722055631 | 8 BLISTER PACK in 1 CARTON (31722-556-31) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 7, 2021 | |
| 31722-556-32 | 31722055632 | 8 BLISTER PACK in 1 CARTON (31722-556-32) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 7, 2021 | |
| 31722-556-60 | 31722055660 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-556-60)Marketed from Jun 7, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Lopinavir and ritonavir
- Generic name (nonproprietary)
- lopinavir and ritonavir
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091677
- 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 31722-556_c3de2763-2221-d566-e053-2995a90ab15fSPL ID c3de2763-2221-d566-e053-2995a90ab15fSPL set ID 4e5005b8-f00c-4671-be09-bb927190760fRxCUI 597730, 746645UNII 2494G1JF75, O3J8G9O825UPC 0331722603607, 0331722556125
- 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
N431722055612followed by a unit qualifier and the quantityPackage 31722-0556-12. 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)
Lopinavir and ritonavir tablets are 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 lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)]. Lopinavir and ritonavir tablets are 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 31722-556
- What is NDC 31722-556?
- 31722-556 is the product NDC for Lopinavir and ritonavir, Lopinavir 200 mg/1; Ritonavir 50 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lopinavir and ritonavir.
- What is the active ingredient?
- Lopinavir, Ritonavir.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lopinavir and ritonavir?
- 5 other product NDCs are listed under this name. See all Lopinavir and ritonavir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lopinavir and ritonavir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lopinavir and Ritonavir | Lopinavir 100 mg/1; Ritonavir 25 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-163 | 33342-0163-09 |
| Lopinavir and Ritonavir | Lopinavir 200 mg/1; Ritonavir 50 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-164 | 33342-0164-09 |
| Lopinavir and Ritonavir | Lopinavir 100 mg/1; Ritonavir 25 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-933 | 42385-0933-60 |
| Lopinavir and Ritonavir | Lopinavir 200 mg/1; Ritonavir 50 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-934 | 42385-0934-12 |
| Lopinavir and ritonavir | Lopinavir 100 mg/1; Ritonavir 25 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-603 | 31722-0603-1231722-0603-60 |
Other NDCs under ANDA 091677
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 |
|---|---|---|---|---|
| Lopinavir and ritonavir | Lopinavir 100 mg/1; Ritonavir 25 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-603 |