Epclusa NDC 61958-2203

NDC codes

FDA NDC Directory

Product NDC (as listed)61958-2203Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61958-2203Add 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
61958-2203-1	61958220301	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2203-1)Marketed from Mar 19, 2020

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): Epclusa
Generic name (nonproprietary): velpatasvir and sofosbuvir
Active ingredients: Velpatasvir — 50 mg/1Sofosbuvir — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Gilead Sciences, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208341
Marketing start: Mar 19, 2020
Listing expires: Dec 31, 2026
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 61958-2203_4e28b652-df20-450d-9f6e-4cc6e355e223SPL ID 4e28b652-df20-450d-9f6e-4cc6e355e223SPL set ID 7f30631a-ee3b-4cfe-866b-964df3f0a44fRxCUI 1799212, 1799218, 2288814, 2288816, 2584196, 2584199, 2584200, 2584201UNII WJ6CA3ZU8B, KCU0C7RS7Z
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

N461958220301 followed by a unit qualifier and the quantity

Package 61958-2203-01. 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 Jun 5, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

EPCLUSA 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. EPCLUSA 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, 5, or 6 infection ( 1 ): without cirrho…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
Product	Strength	Form · route	Labeler	Product NDC
Sofosbuvir and Velpatasvirvelpatasvir and sofosbuvir	Velpatasvir 100 mg/1; Sofosbuvir 400 mg/1	Tablet, Film coatedOral	Asegua Therapeutics LLC	72626-2701
Epclusavelpatasvir and sofosbuvir	Velpatasvir 100 mg/1; Sofosbuvir 400 mg/1	Tablet, Film coatedOral	Gilead Sciences, Inc.	61958-2201