Prezcobix Ped NDC 59676-577

NDC codes

FDA NDC Directory

Product NDC (as listed)59676-577Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59676-0577Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59676-577-30	59676057730	30 TABLET, FOR SUSPENSION in 1 BOTTLE (59676-577-30)Marketed from Feb 27, 2026

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 Ped
Generic name (nonproprietary): darunavir ethanolate and cobicistat
Active ingredients: Darunavir ethanolate — 600 mg/1Cobicistat — 90 mg/1
Dosage form: Tablet, For suspension
Route: Oral
Labeler: Janssen Products, LP
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 220092
Marketing start: Feb 27, 2026
Listing expires: Dec 31, 2027
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 59676-577_37a1f6a0-296b-47ee-8060-9e89b01eae72SPL ID 37a1f6a0-296b-47ee-8060-9e89b01eae72SPL set ID 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9fRxCUI 1600704, 1600710, 2710424, 2710426, 2738995, 2738999UNII LW2E03M5PG, 33O78XF0BWUPC 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

N459676057730 followed by a unit qualifier and the quantity

Package 59676-0577-30. 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 Feb 1, 2026.

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.

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