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United States · US · US:71335-2784_545ff7d3-04a5-43a2-9417-f35a6c5a892b
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11713352784130 TABLET, FILM COATED in 1 BOTTLE (71335-2784-1)
- ndc117133527842100 TABLET, FILM COATED in 1 BOTTLE (71335-2784-2)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A213286
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": "71335-2784_545ff7d3-04a5-43a2-9417-f35a6c5a892b",
"productndc": "71335-2784",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213286",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Apr 8, 2020"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Apr 8, 2020"
}
],
"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": "ANDA213286",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine",
"start_marketing_date": "20200408",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AB03.
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