What is NDC 68071-3910?

68071-3910 is the product NDC for Darunavir, Darunavir propylene glycolate 800 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Darunavir NDC 68071-3910 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3910Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3910Add 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
68071-3910-3	6807139100368071391003	3 TABLET, FILM COATED in 1 BOTTLE (68071-3910-3)Marketed from Nov 4, 2025

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 propylene glycolate — 800 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NuCare Pharmaceuticals, Inc.NDC labeler code 68071
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 68071-3910_42de77fa-91bb-20bb-e063-6394a90ad54dSPL ID 42de77fa-91bb-20bb-e063-6394a90ad54dSPL set ID 42cc1b58-2660-f0be-e063-6394a90abe4cRxCUI 1359269UNII 6M6D7F3VC7UPC 0368071391039
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

N468071391003 followed by a unit qualifier and the quantity

Package 68071-3910-03. 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 5, 2025.

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)

About NDC 68071-3910

What is NDC 68071-3910?: 68071-3910 is the product NDC for Darunavir, Darunavir propylene glycolate 800 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals, Inc.. 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 propylene glycolate.
Who is the labeler?: NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Darunavir	Darunavir 600 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-088	31722-0088-60
Darunavir	Darunavir 800 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-089	31722-0089-30
Darunavir	Darunavir dihydrate 800 mg/1	TabletOral	American Health Packaging	60687-819	60687-0819-21
Darunavir	Darunavir dihydrate 600 mg/1	TabletOral	American Health Packaging	60687-808	60687-0808-21
Darunavir	Darunavir 600 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1745	70771-1745-0570771-1745-0670771-1745-08
Darunavir	Darunavir 800 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1746	70771-1746-0370771-1746-0570771-1746-09
Darunavir	Darunavir 600 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-147	72578-0147-0572578-0147-1472578-0147-28
Darunavir	Darunavir 800 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-148	72578-0148-0572578-0148-0672578-0148-16
darunavirdarunavir 600 mg	Darunavir hydrate 600 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-737	76282-0737-60
darunavirdarunavir 800 mg	Darunavir hydrate 800 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-738	76282-0738-30

All 24 Darunavir NDCs

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 600 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-085
Darunavir	Darunavir propylene glycolate 800 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-086