Prescription drug · NDA
Paxlovid NDC 0069-5317
nirmatrelvir and ritonavir · Kit · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-5317-20 | 00069531720 | 10 BLISTER PACK in 1 CARTON (0069-5317-20) / 1 KIT in 1 BLISTER PACK (0069-5317-02) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-11) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-1735-11)Marketed from Oct 18, 2023 |
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)
- Paxlovid
- Generic name (nonproprietary)
- nirmatrelvir and ritonavir
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217188
- Marketing start
- Listing expires
- Identifiers
- Product ID 0069-5317_d20f905e-5c85-4ad4-ab46-871ce4f6669eSPL ID d20f905e-5c85-4ad4-ab46-871ce4f6669eSPL set ID 8a99d6d6-fd9e-45bb-b1bf-48c7f761232aRxCUI 900575, 2587897, 2587898, 2587899, 2599542, 2599543, 2704986, 2704987
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.
- NDC on a medical claim
N400069531720followed by a unit qualifier and the quantityPackage 00069-5317-20. 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)
PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID which includes nirmatrelvir, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (M pro : also referred to as 3CL pro or nsp5 protease) inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor, is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. ( 1 ) Limitations of Use PAXLOVID is not approved for use as pre-e…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 217188
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 |
|---|---|---|---|---|
| Paxlovidnirmatrelvir and ritonavir | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-5450 |
| Paxlovidnirmatrelvir and ritonavir | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-5321 |
| Paxlovidnirmatrelvir and ritonavir | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-5045 |
| Paxlovidnirmatrelvir and ritonavir | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-5434 |