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United States · US · US:55111-150_ec5088cd-9e68-ba14-e274-7e3935c87f17
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Limited
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115511115001100 TABLET, FILM COATED in 1 BOTTLE (55111-150-01)
- ndc115511115005500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05)
- ndc1155111150101000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10)
- ndc11551111503030 TABLET, FILM COATED in 1 BOTTLE (55111-150-30)
- ndc11551111507810 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A076006
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": "55111-150_ec5088cd-9e68-ba14-e274-7e3935c87f17",
"productndc": "55111-150",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076006",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jan 30, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Apr 23, 2018"
}
],
"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": "ANDA076006",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine",
"start_marketing_date": "20160930",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AB03.
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