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United States · US · US:42291-800_4875aee4-c75a-ee36-e063-6394a90a9ce8
Tenofovir Disoproxil Fumarate
Orange BookUNIISPLATC J05AF07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeJ05AF07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11422918003030 TABLET, FILM COATED in 1 BOTTLE (42291-800-30)
Annotations
UNII (FDA Substance ID)
OTT9J7900I
TENOFOVIR DISOPROXIL FUMARATE
RxCUI 322248
Orange Book
A090636
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": "42291-800_4875aee4-c75a-ee36-e063-6394a90a9ce8",
"productndc": "42291-800",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090636",
"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": "ANDA090636",
"marketing_category": "ANDA",
"nonproprietary_name": "Tenofovir Disoproxil Fumarate",
"start_marketing_date": "20190110",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J05AF07.
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