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United States · US · US:42385-922_0e18774c-a32c-4961-9684-f5c6ffce64a1
Atazanavir
In shortageOrange BookUNIISPLATC J05AE08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeJ05AE08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11423859223030 CAPSULE in 1 BOTTLE (42385-922-30)
- ndc1142385922375 BLISTER PACK in 1 CARTON (42385-922-37) / 6 CAPSULE in 1 BLISTER PACK (42385-922-06)
Annotations
UNII (FDA Substance ID)
4MT4VIE29P
ATAZANAVIR SULFATE
RxCUI 358299
Orange Book
A212579
ABABAB
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": "42385-922_0e18774c-a32c-4961-9684-f5c6ffce64a1",
"productndc": "42385-922",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212579",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Apr 30, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "002",
"approval_date": "Apr 30, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "003",
"approval_date": "Apr 30, 2021"
}
],
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212579",
"marketing_category": "ANDA",
"nonproprietary_name": "Atazanavir",
"start_marketing_date": "20210430",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J05AE08.
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