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United States · US · US:0832-6032_178bf3b7-fdee-454e-9446-822a1077d985
Fluoxetine hydrochloride
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1108326032121 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A216953
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I9W7N6B1KJ",
"rxcui": "227224",
"inchikey": "GIYXAJPCNFJEHY-UHFFFAOYSA-N",
"display_name": "FLUOXETINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1a2a5194-b793-4c62-a177-040dad38526b": {
"match": "brand_token",
"title": "FLUOXETINE CAPSULE [PROFICIENT RX LP]",
"spl_version": "6",
"published_date": "2026-05-29"
}
},
"productid": "0832-6032_178bf3b7-fdee-454e-9446-822a1077d985",
"productndc": "0832-6032",
"dosage_form": "FOR SOLUTION",
"orange_book": {
"appl_no": "216953",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 20MG BASE/5ML",
"product_no": "001",
"approval_date": "Nov 15, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOXETINE HYDROCHLORIDE",
"proprietary_name": "Fluoxetine hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA216953",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine hydrochloride",
"start_marketing_date": "20221115",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB03.
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