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United States · US · US:0074-2625_2c392930-500d-4e9b-93ac-317c4d48251c
Mavyret
Orange BookUNIISPLATC J05AP
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeJ05AP
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1100742625044 CARTON in 1 CARTON (0074-2625-04) / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1100742625284 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK
- ndc1100742625562 CARTON in 1 CARTON (0074-2625-56) / 4 CARTON in 1 CARTON / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK
- ndc11007426258484 TABLET, FILM COATED in 1 BOTTLE (0074-2625-84)
Annotations
UNII (FDA Substance ID)
K6BUU8J72P
GLECAPREVIR
RxCUI 1940635
Orange Book
N209394
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K6BUU8J72P",
"rxcui": "1940635",
"inchikey": "MLSQGNCUYAMAHD-ITNVBOSISA-N",
"display_name": "GLECAPREVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7bf99777-0401-9095-8645-16c6e907fcc0": {
"match": "brand_token",
"title": "MAVYRET (GLECAPREVIR AND PIBRENTASVIR) TABLET, FILM COATED MAVYRET (GLECAPREVIR AND PIBRENTASVIR) PELLET [ABBVIE INC.]",
"spl_version": "200",
"published_date": "2026-01-30"
}
},
"productid": "0074-2625_2c392930-500d-4e9b-93ac-317c4d48251c",
"productndc": "0074-2625",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209394",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG;40MG",
"product_no": "001",
"approval_date": "Aug 3, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLECAPREVIR; PIBRENTASVIR",
"proprietary_name": "Mavyret",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA209394",
"marketing_category": "NDA",
"nonproprietary_name": "Glecaprevir and Pibrentasvir",
"start_marketing_date": "20170803",
"active_numerator_strength": "100; 40"
}Related drugs
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