Prescription drug · NDA
Sovaldi (Sofosbuvir) NDC 61958-1504
Sofosbuvir 150 mg/1 · Pellet · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-1504-1 | 6195815040161958150401 | 60 PELLET in 1 PACKET (61958-1504-1)Marketed from Aug 28, 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)
- Sovaldi
- Generic name (nonproprietary)
- sofosbuvir
- Active ingredients
- Sofosbuvir — 150 mg/1
- Dosage form
- Pellet
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.NDC labeler code 61958
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212480
- Marketing start
- Listing expires
- Other FDA classes
- RNA Replicase Inhibitors (Mechanism)
- Identifiers
- Product ID 61958-1504_74c52ec6-8358-4e63-b299-64ec1ff7f434SPL ID 74c52ec6-8358-4e63-b299-64ec1ff7f434SPL set ID 80beab2c-396e-4a37-a4dc-40fdb62859cfRxCUI 1484916, 1484922, 2203891, 2203893, 2203993, 2203999, 2204090, 2204092UNII WJ6CA3ZU8B
- Pharmacologic class
- 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
N461958150401followed by a unit qualifier and the quantityPackage 61958-1504-01. 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)
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. ( 1 ) Pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. ( 1 ) Adult Patients: SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Dosage and Administration (2.2) , and Clinical Stud…
Excerpt only. Read the full label for complete information.
About NDC 61958-1504
- What is NDC 61958-1504?
- 61958-1504 is the product NDC for Sovaldi (sofosbuvir), Sofosbuvir 150 mg/1 pellet, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sovaldi (Sofosbuvir).
- What is the active ingredient?
- Sofosbuvir.
- Who is the labeler?
- Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sovaldi?
- 3 other product NDCs are listed under this name. See all Sovaldi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sovaldi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sovaldisofosbuvir | Sofosbuvir 200 mg/1 | Tablet, Film coatedOral | Gilead Sciences, Inc. | 61958-1503 | 61958-1503-01 |
| Sovaldisofosbuvir | Sofosbuvir 200 mg/1 | PelletOral | Gilead Sciences, Inc. | 61958-1505 | 61958-1505-01 |
| Sovaldisofosbuvir | Sofosbuvir 400 mg/1 | Tablet, Film coatedOral | Gilead Sciences, Inc. | 61958-1501 | 61958-1501-01 |
Other NDCs under NDA 212480
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sovaldisofosbuvir | Sofosbuvir 200 mg/1 | PelletOral | Gilead Sciences, Inc. | 61958-1505 |