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United States · US · US:61958-0404_1b2267fa-9978-4429-ac13-09a5d43b3093
Viread
Orange BookUNIISPLATC J05AF07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AF07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619580404130 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1)
Annotations
UNII (FDA Substance ID)
OTT9J7900I
TENOFOVIR DISOPROXIL FUMARATE
RxCUI 322248
Orange Book
N021356
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "OTT9J7900I",
"rxcui": "322248",
"inchikey": "VCMJCVGFSROFHV-WZGZYPNHSA-N",
"display_name": "TENOFOVIR DISOPROXIL FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1fdae465-2c01-4030-a73c-fd2f13368453": {
"match": "brand_token",
"title": "VIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]",
"spl_version": "11",
"published_date": "2026-02-16"
}
},
"productid": "61958-0404_1b2267fa-9978-4429-ac13-09a5d43b3093",
"productndc": "61958-0404",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "021356",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Oct 26, 2001"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "150MG",
"product_no": "002",
"approval_date": "Jan 18, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "003",
"approval_date": "Jan 18, 2012"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "250MG",
"product_no": "004",
"approval_date": "Jan 18, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "Viread",
"active_ingred_unit": "mg/1",
"application_number": "NDA021356",
"marketing_category": "NDA",
"nonproprietary_name": "TENOFOVIR DISOPROXIL FUMARATE",
"start_marketing_date": "20120118",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code J05AF07.
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