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United States · US · US:0069-5434_d20f905e-5c85-4ad4-ab46-871ce4f6669e

Paxlovid

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

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
    0069543420
    10 BLISTER PACK in 1 CARTON (0069-5434-20) / 1 KIT in 1 BLISTER PACK (0069-5434-02) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-11) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-1345-11)

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": "0069-5434_d20f905e-5c85-4ad4-ab46-871ce4f6669e",
  "productndc": "0069-5434",
  "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": "20250709",
  "active_numerator_strength": null
}

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