Prescription drug · NDA
Prezcobix (Darunavir ethanolate and cobicistat) NDC 59676-575
Darunavir ethanolate 800 mg/1; Cobicistat 150 mg/1 · Tablet, Film coated · Oral · Janssen Products, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59676-575-30 | 5967605753059676057530 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30)Marketed from Jan 31, 2015 |
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)
- Prezcobix
- Generic name (nonproprietary)
- darunavir ethanolate and cobicistat
- Active ingredients
- Darunavir ethanolate — 800 mg/1Cobicistat — 150 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 205395
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 59676-575_37a1f6a0-296b-47ee-8060-9e89b01eae72SPL ID 37a1f6a0-296b-47ee-8060-9e89b01eae72SPL set ID 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9fRxCUI 1600704, 1600710, 2710424, 2710426, 2738995, 2738999UNII 33O78XF0BW, LW2E03M5PGUPC 0359676575306
- 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
N459676057530followed by a unit qualifier and the quantityPackage 59676-0575-30. 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)
PREZCOBIX and PREZCOBIX PED are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adults and pediatric patients 3 years of age and older weighing at least 15 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V) [see Use in Specific Populations (8.4) and Clinical Studies (14) ] . PREZCOBIX and PREZCOBIX PED are a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and are indicated for the treatment of HIV-1 in treatment-naïve and treatme…
Excerpt only. Read the full label for complete information.
About NDC 59676-575
- What is NDC 59676-575?
- 59676-575 is the product NDC for Prezcobix, Darunavir ethanolate 800 mg/1; Cobicistat 150 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?
- Prezcobix (DARUNAVIR ETHANOLATE and COBICISTAT).
- What is the active ingredient?
- Darunavir ethanolate, Cobicistat.
- 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 Prezcobix?
- 2 other product NDCs are listed under this name. See all Prezcobix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prezcobix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prezcobixdarunavir ethanolate and cobicistat | Darunavir ethanolate 675 mg/1; Cobicistat 150 mg/1 | Tablet, Film coatedOral | Janssen Products, LP | 59676-578 | 59676-0578-30 |
| Prezcobixdarunavir ethanolate and cobicistat | Darunavir ethanolate 800 mg/1; Cobicistat 150 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1723 | 50090-1723-00 |
Other NDCs under NDA 205395
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 |
|---|---|---|---|---|
| Prezcobixdarunavir ethanolate and cobicistat | Darunavir ethanolate 800 mg/1; Cobicistat 150 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1723 |
| Prezcobixdarunavir ethanolate and cobicistat | Darunavir ethanolate 675 mg/1; Cobicistat 150 mg/1 | Tablet, Film coatedOral | Janssen Products, LP | 59676-578 |