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United States · US · US:61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6
COMPLERA
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619581101130 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)
Annotations
UNII (FDA Substance ID)
G70B4ETF4S
EMTRICITABINE
RxCUI 276237
Orange Book
N202123
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": {
"d637cfab-f1e8-4eb3-a1b3-f85ca3bec612": {
"match": "brand_token",
"title": "COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]",
"spl_version": "21",
"published_date": "2025-07-25"
}
},
"productid": "61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6",
"productndc": "61958-1101",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202123",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG;EQ 25MG BASE;300MG",
"product_no": "001",
"approval_date": "Aug 10, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "COMPLERA",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA202123",
"marketing_category": "NDA",
"nonproprietary_name": "emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate",
"start_marketing_date": "20110810",
"active_numerator_strength": "200; 25; 300"
}Related drugs
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- GBAbacavir 600mg / Lamivudine 300mg tabletsA A H Pharmaceuticals Ltd
Access this data programmatically
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