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United States · US · US:49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855
CIMDUO
Orange BookUNIISPLATC J05AF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeJ05AF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1149502450931 BOTTLE, PLASTIC in 1 CARTON (49502-450-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
2T8Q726O95
LAMIVUDINE
RxCUI 68244
Orange Book
N022141
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2T8Q726O95",
"rxcui": "68244",
"inchikey": "JTEGQNOMFQHVDC-NKWVEPMBSA-N",
"display_name": "LAMIVUDINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a300f04d-118f-4136-aaf3-ddfd00197f86": {
"match": "brand_token",
"title": "CIMDUO (LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]",
"spl_version": "5",
"published_date": "2025-02-10"
}
},
"productid": "49502-450_e63f53ae-04f8-4bbc-afa1-c62078f09855",
"productndc": "49502-450",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022141",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "300MG;300MG",
"product_no": "001",
"approval_date": "Feb 28, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"proprietary_name": "CIMDUO",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA022141",
"marketing_category": "NDA",
"nonproprietary_name": "Lamivudine and Tenofovir Disoproxil Fumarate",
"start_marketing_date": "20180625",
"active_numerator_strength": "300; 300"
}Related drugs
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- GBAbacavir 600mg / Lamivudine 300mg tabletsLupin Healthcare (UK) Ltd
- GBAbacavir 600mg / Lamivudine 300mg tabletsA A H Pharmaceuticals Ltd
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