Darunavir NDC 72578-148

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-148Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0148Add 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
72578-148-05	72578014805	500 TABLET, FILM COATED in 1 BOTTLE (72578-148-05)Marketed from May 1, 2024
72578-148-06	72578014806	30 TABLET, FILM COATED in 1 BOTTLE (72578-148-06)Marketed from May 1, 2024
72578-148-16	72578014816	90 TABLET, FILM COATED in 1 BOTTLE (72578-148-16)Marketed from May 1, 2024

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): Darunavir
Generic name (nonproprietary): darunavir
Active ingredients: Darunavir — 800 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Viona Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214085
Marketing start: May 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)
Identifiers: Product ID 72578-148_de3be678-a82f-4052-b7ce-728d887d548eSPL ID de3be678-a82f-4052-b7ce-728d887d548eSPL set ID 04a542b3-15ad-4a8a-aab4-ace8e08732f3RxCUI 670026, 1359269UNII YO603Y8113
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

N472578014805 followed by a unit qualifier and the quantity

Package 72578-0148-05. 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 Apr 29, 2024.

Indications (excerpt from the label)

Darunavir, co-administered with ritonavir (darunavir/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 )]. Darunavir 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. Darunavir must be co-administered with ritonavir (darunavir/ritonavir) and with other antiretroviral agents. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214085

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214085
Product	Strength	Form · route	Labeler	Product NDC
Darunavir	Darunavir 600 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-147
Darunavir	Darunavir 600 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1745
Darunavir	Darunavir 800 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1746