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United States · US · US:25000-149_46219345-2dd8-4502-a0fc-1631e354dc98
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc112500014908100 CAPSULE in 1 BOTTLE (25000-149-08)
- ndc112500014912500 CAPSULE in 1 BOTTLE (25000-149-12)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A075465
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": "25000-149_46219345-2dd8-4502-a0fc-1631e354dc98",
"productndc": "25000-149",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "075465",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jan 29, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Jan 29, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Aug 2, 2001"
}
],
"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": "ANDA075465",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20220129",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AB03.
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