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United States · US · US:0074-0579_5d893369-497c-46ee-9b64-ee737fab4225

Venclexta

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAbbVie Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0074057928
    1 KIT in 1 CARTON (0074-0579-28) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

Orange Book
N208573
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "b118a40d-6b56-cee3-10f6-ded821a97018": {
      "match": "brand_token",
      "title": "VENCLEXTA (VENETOCLAX) KIT VENCLEXTA (VENETOCLAX) TABLET, FILM COATED [ABBVIE INC.]",
      "spl_version": "282",
      "published_date": "2026-03-02"
    }
  },
  "productid": "0074-0579_5d893369-497c-46ee-9b64-ee737fab4225",
  "productndc": "0074-0579",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208573",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Apr 11, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Venclexta",
  "active_ingred_unit": null,
  "application_number": "NDA208573",
  "marketing_category": "NDA",
  "nonproprietary_name": "Venetoclax",
  "start_marketing_date": "20160411",
  "active_numerator_strength": null
}

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