What is NDC 72626-2601?

72626-2601 is the product NDC for Ledipasvir and Sofosbuvir, Ledipasvir 90 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.

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 Ledipasvir and Sofosbuvir?

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.

Ledipasvir and Sofosbuvir NDC 72626-2601

NDC codes

FDA NDC Directory

Product NDC (as listed)72626-2601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72626-2601Add 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
72626-2601-1	7262626010172626260101	2 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 1, 2019

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): Ledipasvir and Sofosbuvir
Generic name (nonproprietary): ledipasvir and sofosbuvir
Active ingredients: Ledipasvir — 90 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 205834
Marketing start: Jan 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)RNA Replicase Inhibitors (Mechanism)
Identifiers: Product ID 72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9SPL ID bd8387fe-8338-4241-b084-aec76726f8a9SPL set ID 46f4a73b-0cd6-4902-9092-3ac79e882c1aRxCUI 1591943UNII 013TE6E4WV, 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

N472626260101 followed by a unit qualifier and the quantity

Package 72626-2601-01. 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 Jan 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14) ]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin Ledipasvir and sofosbuvir is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72626-2601

What is NDC 72626-2601?: 72626-2601 is the product NDC for Ledipasvir and Sofosbuvir, Ledipasvir 90 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?: Ledipasvir and Sofosbuvir.
What is the active ingredient?: Ledipasvir, 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 Ledipasvir and Sofosbuvir?: 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 205834

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

FDA NDC Directory listings under NDA 205834
Product	Strength	Form · route	Labeler	Product NDC
Harvoniledipasvir and sofosbuvir	Ledipasvir 90 mg/1; Sofosbuvir 400 mg/1	Tablet, Film coatedOral	Gilead Sciences, Inc	61958-1801
Harvoniledipasvir and sofosbuvir	Ledipasvir 45 mg/1; Sofosbuvir 200 mg/1	Tablet, Film coatedOral	Gilead Sciences, Inc	61958-1803