Atazanavir Sulfate

In shortageOrange BookUNIISPLATC J05AE08

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeJ05AE08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093552706
60 CAPSULE in 1 BOTTLE (0093-5527-06)

Annotations

UNII (FDA Substance ID)

4MT4VIE29P

ATAZANAVIR SULFATE

RxCUI 358299

Orange Book

A091673

ABABABAB

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": {
    "7fbea274-d6b5-4faa-bbf0-05fefab42114": {
      "match": "brand_token",
      "title": "ATAZANAVIR SULFATE (ATAZANAVIR) CAPSULE [AUROBINDO PHARMA LIMITED]",
      "spl_version": "8",
      "published_date": "2025-09-10"
    }
  },
  "productid": "0093-5527_61209ea1-63c7-43fc-ac32-d840a8a0906a",
  "productndc": "0093-5527",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "091673",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Apr 22, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Apr 22, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Apr 22, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "004",
        "approval_date": "Apr 22, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATAZANAVIR SULFATE",
  "shortage_reason": "Atazanavir Sulfate; Cobicistat Tablet",
  "shortage_status": "current",
  "proprietary_name": "Atazanavir Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091673",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atazanavir Sulfate",
  "start_marketing_date": "20171227",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J05AE08.

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