What is NDC 60687-819?

60687-819 is the product NDC for Darunavir, Darunavir dihydrate 800 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.

American Health Packaging, NDC labeler code 60687. 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 60687-819 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60687-819Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60687-0819Add 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
60687-819-21	6068708192160687081921	30 BLISTER PACK in 1 CARTON (60687-819-21) / 1 TABLET in 1 BLISTER PACK (60687-819-11)Marketed from Jun 25, 2024

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 dihydrate — 800 mg/1
Dosage form: Tablet
Route: Oral
Labeler: American Health PackagingNDC labeler code 60687
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206288
Marketing start: Jun 25, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)
Identifiers: Product ID 60687-819_5b8bf473-5fd1-7962-e063-6394a90a405fSPL ID 5b8bf473-5fd1-7962-e063-6394a90a405f
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

N460687081921 followed by a unit qualifier and the quantity

Package 60687-0819-21. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60687-819

What is NDC 60687-819?: 60687-819 is the product NDC for Darunavir, Darunavir dihydrate 800 mg/1 tablet, listed with the FDA by American Health Packaging. 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 dihydrate.
Who is the labeler?: American Health Packaging, NDC labeler code 60687. 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 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
Darunavir	Darunavir 600 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	60219-1144	60219-1144-06

All 24 Darunavir NDCs

Other NDCs under ANDA 206288

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

FDA NDC Directory listings under ANDA 206288
Product	Strength	Form · route	Labeler	Product NDC
Darunavir	Darunavir dihydrate 600 mg/1	TabletOral	American Health Packaging	60687-808
darunavirdarunavir 600 mg	Darunavir hydrate 600 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-737
darunavirdarunavir 800 mg	Darunavir hydrate 800 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-738
Darunavir 600 and 800 mgdarunavir	Darunavir dihydrate 800 mg/1	TabletOral	Bryant Ranch Prepack	63629-5686
Darunavir 600 and 800 mgdarunavir	Darunavir hydrate 800 mg/1	TabletOral	Cipla USA Inc.	69097-244
Darunavir 600 and 800 mgdarunavir	Darunavir hydrate 600 mg/1	TabletOral	Cipla USA Inc.	69097-248