INGREZZA

Orange BookUNIISPLATC N07XX13

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNeurocrine Biosciences, Inc.

CountryUS (United States)

ATC codeN07XX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7037010801
30 CAPSULE in 1 BOTTLE (70370-1080-1)

Annotations

UNII (FDA Substance ID)

5SML1T733B

VALBENAZINE TOSYLATE

RxCUI 1923002

Orange Book

N209241

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5SML1T733B",
    "rxcui": "1923002",
    "inchikey": "BXGKAGLZHGYAMW-TZYFFPFWSA-N",
    "display_name": "VALBENAZINE TOSYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "70370-1080_bbfcd3d3-5b8b-411d-9cb6-3521a4e36e6b",
  "productndc": "70370-1080",
  "dosage_form": "CAPSULE",
  "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": "VALBENAZINE TOSYLATE",
  "proprietary_name": "INGREZZA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209241",
  "marketing_category": "NDA",
  "nonproprietary_name": "Valbenazine",
  "start_marketing_date": "20171004",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code N07XX13.

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