NDC codes

FDA NDC Directory
Product NDC (as listed)72626-2701Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72626-2701Add 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
72626-2701-172626270101726262701012 BLISTER PACK in 1 CARTON (72626-2701-1) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 14, 2018

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)
Sofosbuvir and Velpatasvir
Generic name (nonproprietary)
velpatasvir and sofosbuvir
Active ingredients
Velpatasvir — 100 mg/1Sofosbuvir — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Asegua Therapeutics LLCNDC labeler code 72626
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 208341
Marketing start
Listing expires
Other FDA classes
Breast Cancer Resistance Protein Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 2B1 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)RNA Replicase Inhibitors (Mechanism)
Identifiers
Product ID 72626-2701_314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7dSPL ID 314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7dSPL set ID d0c1a945-4440-4b5c-81aa-693ed3db597cRxCUI 1799212UNII KCU0C7RS7Z, WJ6CA3ZU8B
Pharmacologic class
Hepatitis C Virus NS5A Inhibitor; Hepatitis C Virus Nucleotide Analog NS5B Polymerase 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

N472626270101 followed by a unit qualifier and the quantity

Package 72626-2701-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2 , 2.3 , 2.4 ) and Clinical Studies (14) ] : without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. Sofosbuvir and velpatasvir is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72626-2701

What is NDC 72626-2701?
72626-2701 is the product NDC for Sofosbuvir and Velpatasvir, Velpatasvir 100 mg/1; Sofosbuvir 400 mg/1 tablet, film coated, listed with the FDA by Asegua Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sofosbuvir and Velpatasvir (Velpatasvir and Sofosbuvir).
What is the active ingredient?
Velpatasvir, Sofosbuvir.
Who is the labeler?
Asegua Therapeutics LLC, NDC labeler code 72626. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sofosbuvir and Velpatasvir?
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.

Other NDCs under NDA 208341

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

FDA NDC Directory listings under NDA 208341
ProductStrengthForm · routeLabelerProduct NDC
Epclusavelpatasvir and sofosbuvirVelpatasvir 100 mg/1; Sofosbuvir 400 mg/1Tablet, Film coatedOralGilead Sciences, Inc.61958-2201
Epclusavelpatasvir and sofosbuvirVelpatasvir 50 mg/1; Sofosbuvir 200 mg/1Tablet, Film coatedOralGilead Sciences, Inc.61958-2203

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