🇺🇸
United States · US · US:42385-801_7193c90e-456c-4cfb-8181-65a1618dae51
emtricitabine, rilpivirine and tenofovir disoproxil fumarate
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLaurus Labs Limited
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11423858013030 TABLET, FILM COATED in 1 BOTTLE (42385-801-30)
Annotations
UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
A220232
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G70B4ETF4S",
"rxcui": "276237",
"inchikey": "XQSPYNMVSIKCOC-NTSWFWBYSA-N",
"display_name": "EMTRICITABINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7193c90e-456c-4cfb-8181-65a1618dae51": {
"match": "brand_token",
"title": "EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED]",
"spl_version": "1",
"published_date": "2026-03-06"
}
},
"productid": "42385-801_7193c90e-456c-4cfb-8181-65a1618dae51",
"productndc": "42385-801",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "220232",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG;EQ 25MG BASE;300MG",
"product_no": "001",
"approval_date": "Mar 4, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "emtricitabine, rilpivirine and tenofovir disoproxil fumarate",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA220232",
"marketing_category": "ANDA",
"nonproprietary_name": "emtricitabine, rilpivirine and tenofovir disoproxil fumarate",
"start_marketing_date": "20260305",
"active_numerator_strength": "200; 25; 300"
}Related drugs
Other records sharing ATC code J05AF.
- GBAbacavir 600mg / Lamivudine 300mg tabletsSun Pharma UK Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsMilpharm Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsDr Reddy's Laboratories (UK) Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsTeva UK Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsViatris UK Healthcare Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsZentiva Pharma UK Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsLupin Healthcare (UK) Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsA A H Pharmaceuticals Ltd
Access this data programmatically
Query emtricitabine, rilpivirine and tenofovir disoproxil fumarate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.