Prescription drug · EMERGENCY USE AUTHORIZATION
pemgarda (Pemivibart) NDC 81960-031
Pemivibart 125 mg/mL · Injection · Intravenous · Invivyd, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81960-031-03 | 81960003103 | 9 VIAL, SINGLE-DOSE in 1 CARTON (81960-031-03) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 22, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- pemgarda
- Generic name (nonproprietary)
- pemivibart
- Active ingredients
- Pemivibart — 125 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Invivyd, IncNDC labeler code 81960
- Product type
- Prescription drug
- Marketing category
- Emergency use authorizationApplication EUA 000122
- Marketing start
- Listing expires
- Identifiers
- Product ID 81960-031_4b1b8d43-0bf4-849a-e063-6294a90abfb4SPL ID 4b1b8d43-0bf4-849a-e063-6294a90abfb4SPL set ID 0bdc20a9-791f-9a06-e063-6394a90a84ccRxCUI 2677805, 2677811UNII 557S3L3FAP
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
N481960003103followed by a unit qualifier and the quantityPackage 81960-0031-03. 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)
1 EMERGENCY USE AUTHORIZATION FOR PEMGARDA The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PEMGARDA (pemivibart) for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older weighing at least 40 kg): Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and Who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate response to COVID-19 vaccination. Med…
Excerpt only. Read the full label for complete information.
About NDC 81960-031
- What is NDC 81960-031?
- 81960-031 is the product NDC for pemgarda (pemivibart), Pemivibart 125 mg/mL injection, listed with the FDA by Invivyd, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- pemgarda (Pemivibart).
- What is the active ingredient?
- Pemivibart.
- Who is the labeler?
- Invivyd, Inc, NDC labeler code 81960. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for pemgarda?
- 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.