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United States · US · US:70370-2046_bbfcd3d3-5b8b-411d-9cb6-3521a4e36e6b

INGREZZA

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    7037020461
    1 BLISTER PACK in 1 CARTON (70370-2046-1) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
N209241
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "4c970164-cafb-421f-9eb5-c226ef0a3417": {
      "match": "brand_token",
      "title": "INGREZZA (VALBENAZINE) CAPSULE INGREZZA (VALBENAZINE) KIT INGREZZA SPRINKLE (VALBENAZINE) CAPSULE [NEUROCRINE BIOSCIENCES, INC.]",
      "spl_version": "34",
      "published_date": "2026-04-22"
    }
  },
  "productid": "70370-2046_bbfcd3d3-5b8b-411d-9cb6-3521a4e36e6b",
  "productndc": "70370-2046",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209241",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "001",
        "approval_date": "Apr 11, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "002",
        "approval_date": "Oct 4, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Apr 23, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "INGREZZA",
  "active_ingred_unit": null,
  "application_number": "NDA209241",
  "marketing_category": "NDA",
  "nonproprietary_name": "Valbenazine",
  "start_marketing_date": "20230818",
  "active_numerator_strength": null
}

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