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United States · US · US:72888-456_4e8dc87f-5d2d-5277-e063-6394a90ae95f

Atomoxetine hydrochloride

Orange BookUNIISPLATC N06BA09

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

Identification

ManufacturerAdvagen Pharma Ltd.
CountryUS (United States)
ATC codeN06BA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7288845601
    1 BOTTLE, GLASS in 1 CARTON (72888-456-01) / 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": {
    "f266ab7b-5a68-42b5-b204-e3249bea0aed": {
      "match": "brand_token",
      "title": "ATOMOXETINE (ATOMOXETINE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-05-26"
    }
  },
  "productid": "72888-456_4e8dc87f-5d2d-5277-e063-6394a90ae95f",
  "productndc": "72888-456",
  "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": "Atomoxetine hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA220320",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Atomoxetine hydrochloride",
  "start_marketing_date": "20260320",
  "active_numerator_strength": "4"
}

Related drugs

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