Harvoni NDC 61958-1801

NDC codes

FDA NDC Directory

Product NDC (as listed)61958-1801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61958-1801Add 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
61958-1801-1	61958180101	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1)Marketed from Oct 10, 2014

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): Harvoni
Generic name (nonproprietary): ledipasvir and sofosbuvir
Active ingredients: Ledipasvir — 90 mg/1Sofosbuvir — 400 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Gilead Sciences, Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205834
Marketing start: Oct 10, 2014
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 61958-1801_6fc15183-879a-4402-af66-edf57754e31fSPL ID 6fc15183-879a-4402-af66-edf57754e31fSPL set ID f4ec77e4-bae8-4db0-b3d5-bde09c5fa075RxCUI 1591943, 1591949, 2203895, 2203897, 2204100, 2204102, 2204103, 2204104UNII WJ6CA3ZU8B, 013TE6E4WV
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

N461958180101 followed by a unit qualifier and the quantity

Package 61958-1801-01. 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 Dec 26, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

HARVONI 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 HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
Ledipasvir and Sofosbuvir	Ledipasvir 90 mg/1; Sofosbuvir 400 mg/1	Tablet, Film coatedOral	Asegua Therapeutics LLC	72626-2601
Harvoniledipasvir and sofosbuvir	Ledipasvir 45 mg/1; Sofosbuvir 200 mg/1	Tablet, Film coatedOral	Gilead Sciences, Inc	61958-1803