Prescription drug · NDA
Prezcobix (Darunavir ethanolate and cobicistat) NDC 50090-1723
Darunavir ethanolate 800 mg/1; Cobicistat 150 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1723-0 | 5009017230050090172300 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)Marketed from Mar 4, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-1723_c5bd2c9e-5b7b-4404-bcd2-a82a46da19d8SPL ID c5bd2c9e-5b7b-4404-bcd2-a82a46da19d8SPL set ID 16ca460a-3c89-4697-8f45-972615a2a518RxCUI 1600704, 1600710UNII 33O78XF0BW, LW2E03M5PG
- 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
N450090172300followed by a unit qualifier and the quantityPackage 50090-1723-00. 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 is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). PREZCOBIX is a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated sub…
Excerpt only. Read the full label for complete information.
About NDC 50090-1723
- What is NDC 50090-1723?
- 50090-1723 is the product NDC for Prezcobix, Darunavir ethanolate 800 mg/1; Cobicistat 150 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 | Janssen Products, LP | 59676-575 | 59676-0575-30 |
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 | Janssen Products, LP | 59676-575 |
| Prezcobixdarunavir ethanolate and cobicistat | Darunavir ethanolate 675 mg/1; Cobicistat 150 mg/1 | Tablet, Film coatedOral | Janssen Products, LP | 59676-578 |