Darunavir NDC 59651-085

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0085Add 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
59651-085-60	59651008560	60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60)Marketed from Nov 28, 2023

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 propylene glycolate — 600 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210677
Marketing start: Nov 28, 2023
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 59651-085_2b5403e0-28fe-44ef-9b80-f754181ba220SPL ID 2b5403e0-28fe-44ef-9b80-f754181ba220SPL set ID 88910ad0-6dc3-4a47-8a6b-5c6ee79f2a93RxCUI 670026, 1359269UNII 6M6D7F3VC7
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

N459651008560 followed by a unit qualifier and the quantity

Package 59651-0085-60. 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 Jun 22, 2024.

Indications (excerpt from the label)

Darunavir tablets, 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 tablets 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 210677

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

FDA NDC Directory listings under ANDA 210677
Product	Strength	Form · route	Labeler	Product NDC
Darunavir	Darunavir propylene glycolate 800 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3910
Darunavir	Darunavir propylene glycolate 800 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-086