🇺🇸
United States · US · US:42543-727_f1764ef9-4324-4e97-a72c-d54bb09245ba
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVensun Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114254372701100 CAPSULE in 1 BOTTLE (42543-727-01)
- ndc114254372705500 CAPSULE in 1 BOTTLE (42543-727-05)
- ndc11425437273030 CAPSULE in 1 BOTTLE (42543-727-30)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A204597
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": "42543-727_f1764ef9-4324-4e97-a72c-d54bb09245ba",
"productndc": "42543-727",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204597",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Mar 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Mar 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Mar 16, 2015"
}
],
"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": "ANDA204597",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20150316",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AB03.
Access this data programmatically
Query Fluoxetine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.