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United States · US · US:69097-533_cee87535-9401-4baf-920c-7184d8959c09
Tenofovir disoproxil fumarate
Orange BookUNIISPLATC J05AF07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeJ05AF07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11690975330230 TABLET in 1 BOTTLE (69097-533-02)
- ndc1169097533151000 TABLET in 1 BOTTLE (69097-533-15)
Annotations
UNII (FDA Substance ID)
OTT9J7900I
TENOFOVIR DISOPROXIL FUMARATE
RxCUI 322248
Orange Book
A078800
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": "69097-533_cee87535-9401-4baf-920c-7184d8959c09",
"productndc": "69097-533",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078800",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Jan 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": "ANDA078800",
"marketing_category": "ANDA",
"nonproprietary_name": "Tenofovir disoproxil fumarate",
"start_marketing_date": "20180126",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J05AF07.
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