Symtuza NDC 59676-800

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	59676080030	30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)Marketed from Jul 17, 2018
59676-800-99	59676080099	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 LP
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

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