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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
- ndc11000336311260 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"strength": "EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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"strength": "EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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
Other records sharing ATC code J05AE08.
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