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United States · US · US:0003-3631_510c2d51-4943-401c-a008-ea22f61c6938

REYATAZ

In shortageOrange BookUNIISPLATC J05AE08

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

Identification

ManufacturerE.R. Squibb & Sons, L.L.C.
CountryUS (United States)
ATC codeJ05AE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0003363112
    60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3631-12)

Annotations

UNII (FDA Substance ID)
4MT4VIE29P
ATAZANAVIR SULFATE
RxCUI 358299
Orange Book
N021567
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Atazanavir Sulfate; Cobicistat Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "4MT4VIE29P",
    "rxcui": "358299",
    "inchikey": "DQSGVVGOPRWTKI-QVFAWCHISA-N",
    "display_name": "ATAZANAVIR SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "165cff62-b284-4a27-a65d-9ec8a5bfcdd8": {
      "match": "brand_token",
      "title": "REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]",
      "spl_version": "37",
      "published_date": "2025-07-18"
    }
  },
  "productid": "0003-3631_510c2d51-4943-401c-a008-ea22f61c6938",
  "productndc": "0003-3631",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "021567",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 20, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jun 20, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Jun 20, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "004",
        "approval_date": "Oct 16, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATAZANAVIR SULFATE",
  "shortage_reason": "Atazanavir Sulfate; Cobicistat Tablet",
  "shortage_status": "current",
  "proprietary_name": "REYATAZ",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021567",
  "marketing_category": "NDA",
  "nonproprietary_name": "ATAZANAVIR",
  "start_marketing_date": "20030624",
  "active_numerator_strength": "200"
}

Related drugs

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