Darunavir NDC 60219-1144

NDC codes

FDA NDC Directory

Product NDC (as listed)60219-1144Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60219-1144Add 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
60219-1144-6	60219114406	1 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Dec 9, 2023

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): Darunavir
Generic name (nonproprietary): darunavir
Active ingredients: Darunavir — 600 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212493
Marketing start: Dec 9, 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 60219-1144_7fb8acac-13ca-47ca-8b06-d12900d4943bSPL ID 7fb8acac-13ca-47ca-8b06-d12900d4943bSPL set ID 92b286d5-1ee5-435b-9e1d-2e95c7f2ec69RxCUI 670026, 1359269UNII YO603Y8113UPC 0360219114463, 0360219114531
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

N460219114406 followed by a unit qualifier and the quantity

Package 60219-1144-06. 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 21, 2023.

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 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 212493

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

FDA NDC Directory listings under ANDA 212493
Product	Strength	Form · route	Labeler	Product NDC
Darunavir	Darunavir 800 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1145