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United States · US · US:64380-902_35d9874e-1471-484c-b625-29e70a190e10
FLUOXETINE
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11643809020430 TABLET in 1 BOTTLE (64380-902-04)
- ndc116438090206100 TABLET in 1 BOTTLE (64380-902-06)
- ndc1164380902081000 TABLET in 1 BOTTLE (64380-902-08)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A212684
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": "64380-902_35d9874e-1471-484c-b625-29e70a190e10",
"productndc": "64380-902",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212684",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Apr 5, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Apr 5, 2024"
}
],
"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": "ANDA212684",
"marketing_category": "ANDA",
"nonproprietary_name": "fluoxetine",
"start_marketing_date": "20240812",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AB03.
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