Prescription drug · NDA
Prezista (Darunavir) NDC 59676-562
Darunavir ethanolate 600 mg/1 · Tablet, Film coated · Oral · Janssen Products LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59676-562-01 | 5967605620159676056201 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-562-01)Marketed from Mar 8, 2008 |
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)
- Prezista
- Generic name (nonproprietary)
- darunavir
- Active ingredients
- Darunavir ethanolate — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Janssen Products LPNDC labeler code 59676
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021976
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)
- Identifiers
- Product ID 59676-562_3d80bc62-24ac-c092-e063-6394a90a7bbaSPL ID 3d80bc62-24ac-c092-e063-6394a90a7bbaSPL set ID 814301f9-c990-46a5-b481-2879a521a16fRxCUI 670026, 794610, 831868, 831870, 850455, 850457, 1236628, 1236632, 1359269, 1359271UNII 33O78XF0BWUPC 0359676563013, 0359676562016, 0359676564010, 0359676566304
- Pharmacologic class
- 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
N459676056201followed by a unit qualifier and the quantityPackage 59676-0562-01. 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)
PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 59676-562
- What is NDC 59676-562?
- 59676-562 is the product NDC for Prezista (darunavir), Darunavir ethanolate 600 mg/1 tablet, film coated, listed with the FDA by Janssen Products LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prezista (Darunavir).
- What is the active ingredient?
- Darunavir ethanolate.
- Who is the labeler?
- Janssen Products LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prezista?
- 4 other product NDCs are listed under this name. See all Prezista NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prezista products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prezistadarunavir | Darunavir ethanolate 800 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-566 | 59676-0566-30 |
| Prezistadarunavir | Darunavir ethanolate 100 mg/mL | SuspensionOral | Janssen Products LP | 59676-565 | 59676-0565-01 |
| Prezistadarunavir | Darunavir ethanolate 150 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-564 | 59676-0564-01 |
| Prezistadarunavir | Darunavir ethanolate 75 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-563 | 59676-0563-01 |
Other NDCs under NDA 021976
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 |
|---|---|---|---|---|
| Prezistadarunavir | Darunavir ethanolate 75 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-563 |
| Prezistadarunavir | Darunavir ethanolate 150 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-564 |
| Prezistadarunavir | Darunavir ethanolate 800 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-566 |