Darunavir NDC 43598-705

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-705Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0705Add 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
43598-705-05	43598070505	500 TABLET, FILM COATED in 1 BOTTLE (43598-705-05)Marketed from Nov 29, 2023
43598-705-30	43598070530	30 TABLET, FILM COATED in 1 BOTTLE (43598-705-30)Marketed from Nov 29, 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 — 800 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Dr.Reddys Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211578
Marketing start: Nov 29, 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 43598-705_82f022df-8075-b1cd-f33b-a5603365dcc2SPL ID 82f022df-8075-b1cd-f33b-a5603365dcc2SPL set ID f5c9cb01-6530-4db0-a326-22a499d1efdfRxCUI 670026, 1359269UNII YO603Y8113UPC 0343598705309, 0343598704609
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

N443598070505 followed by a unit qualifier and the quantity

Package 43598-0705-05. 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 Nov 25, 2023.

Indications (excerpt from the label)

Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are 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 211578

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

FDA NDC Directory listings under ANDA 211578
Product	Strength	Form · route	Labeler	Product NDC
Darunavir	Darunavir 600 mg/1	Tablet, Film coatedOral	Dr.Reddys Laboratories Inc	43598-704