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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
- ndc1130698456021 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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