What is NDC 59676-800?

59676-800 is the product NDC for Symtuza, Darunavir 800 mg/1 + 3 more ingredients tablet, film coated, listed with the FDA by Janssen Products LP. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Symtuza (Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide).

What is the active ingredient?

Darunavir, Cobicistat, Emtricitabine, Tenofovir alafenamide.

Janssen Products LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Symtuza?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Symtuza NDC 59676-800 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59676-800Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59676-0800Add 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
59676-800-30	5967608003059676080030	30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)Marketed from Jul 17, 2018
59676-800-99	5967608009959676080099	30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99)Marketed from Jul 17, 2018 · Sample package

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): Symtuza
Generic name (nonproprietary): darunavir, cobicistat, emtricitabine, and tenofovir alafenamide
Active ingredients: Darunavir — 800 mg/1Cobicistat — 150 mg/1Emtricitabine — 200 mg/1Tenofovir alafenamide — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Janssen Products LPNDC labeler code 59676
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210455
Marketing start: Jul 17, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)Nucleosides (Chemical structure)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 59676-800_a8468da1-a6e7-4a14-a108-23915ccaeee8SPL ID a8468da1-a6e7-4a14-a108-23915ccaeee8SPL set ID 85a17d00-6b7c-41ea-a6b3-5ad924820dabRxCUI 2049671, 2049677UNII YO603Y8113, LW2E03M5PG, G70B4ETF4S, EL9943AG5JUPC 0359676800309
Pharmacologic class: Cytochrome P450 3A Inhibitor; Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor; 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

N459676080030 followed by a unit qualifier and the quantity

Package 59676-0800-30. 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 Apr 17, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg: who have no prior antiretroviral treatment history or who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir. SYMTUZA is a four-drug combination of darunavir (DRV), a human immunodeficiency virus (HIV-1) protease inhibitor, cobicistat (COBI), a CYP3A inhibitor, and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59676-800

What is NDC 59676-800?: 59676-800 is the product NDC for Symtuza, Darunavir 800 mg/1 + 3 more ingredients tablet, film coated, listed with the FDA by Janssen Products LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Symtuza (Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide).
What is the active ingredient?: Darunavir, Cobicistat, Emtricitabine, Tenofovir alafenamide.
Who is the labeler?: Janssen Products LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Symtuza?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.