Prescription drug · NDA
Prevymis (letermovir) NDC 0006-5003
Letermovir 20 mg/mL · Injection, Solution · Intravenous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5003-01 | 00006500301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) / 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)Marketed from Nov 8, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Prevymis
- Generic name (nonproprietary)
- letermovir
- Active ingredients
- Letermovir — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Merck Sharp & Dohme LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209940
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)DNA Terminase Complex Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-5003_282d792e-e2f2-4744-8526-4d18427c55cbSPL ID 282d792e-e2f2-4744-8526-4d18427c55cbSPL set ID 1b49df80-be4f-47e0-a0b7-123f3e69395bRxCUI 1988652, 1988657, 1988660, 1988661, 1988666, 1988671, 1988673, 1988675, 2693185, 2693189, 2693191, 2693193UNII 1H09Y5WO1F
- Pharmacologic class
- Cytomegalovirus DNA Terminase Complex 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400006500301followed by a unit qualifier and the quantityPackage 00006-5003-01. 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 .
Indications (excerpt from the label)
PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). ( 1.1 ) Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). ( 1.2 ) 1.1 CMV Prophylaxis in Hematopoietic Stem Cell Transplant (HSCT) Recipients PREVYMIS ® is indicated for prophylaxis of cytomegalovirus (CMV) infection…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 209940
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 |
|---|---|---|---|---|
| Prevymisletermovir | Letermovir 20 mg/mL | Injection, SolutionIntravenous | Merck Sharp & Dohme LLC | 0006-5004 |