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United States · US · US:68071-3284_1cd4c74a-da49-d12c-e063-6394a90adfdc
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11680713284115 CAPSULE in 1 BOTTLE (68071-3284-1)
- ndc11680713284220 CAPSULE in 1 BOTTLE (68071-3284-2)
- ndc11680713284330 CAPSULE in 1 BOTTLE (68071-3284-3)
- ndc11680713284556 CAPSULE in 1 BOTTLE (68071-3284-5)
- ndc11680713284660 CAPSULE in 1 BOTTLE (68071-3284-6)
- ndc11680713284828 CAPSULE in 1 BOTTLE (68071-3284-8)
- ndc11680713284990 CAPSULE in 1 BOTTLE (68071-3284-9)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A078619
AB1AB1AB
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": "68071-3284_1cd4c74a-da49-d12c-e063-6394a90adfdc",
"productndc": "68071-3284",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078619",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Jan 31, 2008"
}
],
"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": "ANDA078619",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20080131",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB03.
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