NDC codes

FDA NDC Directory
Product NDC (as listed)0069-5321Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00069-5321Add 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 NDC11-digit (billing)PackageCopy
0069-5321-300006953213010 BLISTER PACK in 1 CARTON (0069-5321-30) / 1 KIT in 1 BLISTER PACK (0069-5321-03) * 2 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-02) * 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 0069-5321_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

N400069532130 followed by a unit qualifier and the quantity

Package 00069-5321-30. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 217188

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 217188
ProductStrengthForm · routeLabelerProduct NDC
Paxlovidnirmatrelvir and ritonavir—KitPfizer Laboratories Div Pfizer Inc0069-5317
Paxlovidnirmatrelvir and ritonavir—KitPfizer Laboratories Div Pfizer Inc0069-5450
Paxlovidnirmatrelvir and ritonavir—KitPfizer Laboratories Div Pfizer Inc0069-5045
Paxlovidnirmatrelvir and ritonavir—KitPfizer Laboratories Div Pfizer Inc0069-5434

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Paxlovid NDC 0069-5321 | Med-Code