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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

  • ndc11
    0074262504
    4 CARTON in 1 CARTON (0074-2625-04) / 7 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0074262528
    4 CARTON in 1 CARTON (0074-2625-28) / 7 DOSE PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 DOSE PACK
  • ndc11
    0074262556
    2 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
  • ndc11
    0074262584
    84 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"
}

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