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United States · US · US:13668-473_f8d8c930-c8f9-4186-92fa-6f7a5dabe083
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc111366847301100 TABLET in 1 BOTTLE (13668-473-01)
- ndc1113668473101000 TABLET in 1 BOTTLE (13668-473-10)
- ndc11136684733030 TABLET in 1 BOTTLE (13668-473-30)
- ndc111366847374100 TABLET in 1 CARTON (13668-473-74)
- ndc11136684739128 TABLET in 1 CARTON (13668-473-91)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A206937
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": "13668-473_f8d8c930-c8f9-4186-92fa-6f7a5dabe083",
"productndc": "13668-473",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206937",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Oct 21, 2016"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Oct 21, 2016"
}
],
"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": "ANDA206937",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine",
"start_marketing_date": "20161021",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB03.
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