Paxlovid

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0069531720
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)

Annotations

Orange Book

N217188

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "8a99d6d6-fd9e-45bb-b1bf-48c7f761232a": {
      "match": "brand_token",
      "title": "PAXLOVID (NIRMATRELVIR AND RITONAVIR) KIT [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "12",
      "published_date": "2026-02-23"
    }
  },
  "productid": "0069-5317_d20f905e-5c85-4ad4-ab46-871ce4f6669e",
  "productndc": "0069-5317",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "217188",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;100MG",
        "product_no": "001",
        "approval_date": "May 25, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Paxlovid",
  "active_ingred_unit": null,
  "application_number": "NDA217188",
  "marketing_category": "NDA",
  "nonproprietary_name": "nirmatrelvir and ritonavir",
  "start_marketing_date": "20231018",
  "active_numerator_strength": null
}

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