Atazanavir Sulfate

In shortageOrange BookUNIISPLATC J05AE08

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeJ05AE08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6586271303
3 BLISTER PACK in 1 CARTON (65862-713-03) / 10 CAPSULE in 1 BLISTER PACK (65862-713-10)
ndc11
6586271305
500 CAPSULE in 1 BOTTLE (65862-713-05)
ndc11
6586271330
30 CAPSULE in 1 BOTTLE (65862-713-30)
ndc11
6586271390
90 CAPSULE in 1 BOTTLE (65862-713-90)

Annotations

UNII (FDA Substance ID)

4MT4VIE29P

ATAZANAVIR SULFATE

RxCUI 358299

Orange Book

A204806

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": "65862-713_8f8c56e0-40ee-4643-88f7-d3571ff5a409",
  "productndc": "65862-713",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204806",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Jun 25, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Jun 25, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "003",
        "approval_date": "Jun 25, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 300MG BASE",
        "product_no": "004",
        "approval_date": "Jun 25, 2018"
      }
    ],
    "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": "ANDA204806",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atazanavir",
  "start_marketing_date": "20180625",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code J05AE08.

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