NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2611Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2611Add 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 NDC11-digit (billing)PackageCopy
71335-2611-1713352611017133526110115 TABLET, FILM COATED in 1 BOTTLE (71335-2611-1)Marketed from Mar 11, 2026

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 — 800 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215389
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)
Identifiers
Product ID 71335-2611_585d2da0-738a-48d3-8995-bdb8959a0193SPL ID 585d2da0-738a-48d3-8995-bdb8959a0193SPL set ID e80e44f8-1987-4b78-a63d-a4e4d5122ddbRxCUI 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

N471335261101 followed by a unit qualifier and the quantity

Package 71335-2611-01. 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 .

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 tablets are 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)

About NDC 71335-2611

What is NDC 71335-2611?
71335-2611 is the product NDC for Darunavir, Darunavir 800 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Darunavir.
What is the active ingredient?
Darunavir.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Darunavir?
23 other product NDCs are listed under this name. See all Darunavir NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Darunavir NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DarunavirDarunavir 600 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-08831722-0088-60
DarunavirDarunavir 800 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-08931722-0089-30
DarunavirDarunavir dihydrate 800 mg/1TabletOralAmerican Health Packaging60687-81960687-0819-21
DarunavirDarunavir dihydrate 600 mg/1TabletOralAmerican Health Packaging60687-80860687-0808-21
DarunavirDarunavir 600 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-174570771-1745-0570771-1745-0670771-1745-08
DarunavirDarunavir 800 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-174670771-1746-0370771-1746-0570771-1746-09
DarunavirDarunavir 600 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-14772578-0147-0572578-0147-1472578-0147-28
DarunavirDarunavir 800 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-14872578-0148-0572578-0148-0672578-0148-16
darunavirdarunavir 600 mgDarunavir hydrate 600 mg/1TabletOralEXELAN PHARMACEUTICALS INC.76282-73776282-0737-60
darunavirdarunavir 800 mgDarunavir hydrate 800 mg/1TabletOralEXELAN PHARMACEUTICALS INC.76282-73876282-0738-30

All 24 Darunavir NDCs

Other NDCs under ANDA 215389

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

FDA NDC Directory listings under ANDA 215389
ProductStrengthForm · routeLabelerProduct NDC
DarunavirDarunavir 600 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-184
DarunavirDarunavir 800 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-185

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