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United States · US · US:71209-040_1922c101-5662-4952-9ac2-6470bbfd5ad3
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCadila Pharmaceuticals Limited
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11712090400130 CAPSULE in 1 BOTTLE (71209-040-01)
- ndc117120904005100 CAPSULE in 1 BOTTLE (71209-040-05)
- ndc117120904010500 CAPSULE in 1 BOTTLE (71209-040-10)
- ndc1171209040111000 CAPSULE in 1 BOTTLE (71209-040-11)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A206993
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": "71209-040_1922c101-5662-4952-9ac2-6470bbfd5ad3",
"productndc": "71209-040",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "206993",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "May 23, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "May 23, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "May 23, 2019"
}
],
"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": "ANDA206993",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine",
"start_marketing_date": "20221215",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AB03.
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