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United States · US · US:30698-456_4e746d28-ff24-2255-e063-6294a90a2c71

ATONCY

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerValidus Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06BA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3069845602
    1 BOTTLE, GLASS in 1 CARTON (30698-456-02) / 100 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
57WVB6I2W0
ATOMOXETINE HYDROCHLORIDE
RxCUI 353103
Orange Book
N220320
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "57WVB6I2W0",
    "rxcui": "353103",
    "inchikey": "LUCXVPAZUDVVBT-UNTBIKODSA-N",
    "display_name": "ATOMOXETINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "72d3d8cf-7f3b-479e-bd9f-e204d4118517": {
      "match": "brand_token",
      "title": "ATONCY (ATOMOXETINE HYDROCHLORIDE) SOLUTION [VALIDUS PHARMACEUTICALS LLC]",
      "spl_version": "1",
      "published_date": "2026-04-03"
    }
  },
  "productid": "30698-456_4e746d28-ff24-2255-e063-6294a90a2c71",
  "productndc": "30698-456",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "220320",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE/ML",
        "product_no": "001",
        "approval_date": "Mar 20, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOMOXETINE HYDROCHLORIDE",
  "proprietary_name": "ATONCY",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA220320",
  "marketing_category": "NDA",
  "nonproprietary_name": "Atomoxetine hydrochloride",
  "start_marketing_date": "20260320",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N06BA09.

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