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United States · US · US:50228-421_08a26093-1715-5580-e063-6294a90a4ff6
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115022842101100 TABLET, FILM COATED in 1 BOTTLE (50228-421-01)
- ndc1150228421101000 TABLET, FILM COATED in 1 BOTTLE (50228-421-10)
- ndc11502284213030 TABLET, FILM COATED in 1 BOTTLE (50228-421-30)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A210935
ABAB
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": "50228-421_08a26093-1715-5580-e063-6294a90a4ff6",
"productndc": "50228-421",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210935",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Mar 20, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Mar 20, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOXETINE HYDROCHLORIDE",
"proprietary_name": "Fluoxetine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210935",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine",
"start_marketing_date": "20190320",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB03.
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