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United States · US · US:62135-466_ef9f6879-525d-e5a6-e053-2a95a90ad8be
TENOFOVIR DISOPROXIL FUMARATE
Orange BookUNIISPLATC J05AF07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC.
CountryUS (United States)
ATC codeJ05AF07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11621354663030 TABLET, FILM COATED in 1 BOTTLE (62135-466-30)
Annotations
UNII (FDA Substance ID)
OTT9J7900I
TENOFOVIR DISOPROXIL FUMARATE
RxCUI 322248
Orange Book
A206481
AB
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": {
"7f0bc342-0a0a-1d28-e053-2991aa0a28b9": {
"match": "brand_token",
"title": "TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AVKARE]",
"spl_version": "5",
"published_date": "2026-01-16"
}
},
"productid": "62135-466_ef9f6879-525d-e5a6-e053-2a95a90ad8be",
"productndc": "62135-466",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206481",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Jul 26, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "TENOFOVIR DISOPROXIL FUMARATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206481",
"marketing_category": "ANDA",
"nonproprietary_name": "TENOFOVIR DISOPROXIL FUMARATE Tablets",
"start_marketing_date": "20180731",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J05AF07.
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