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United States · US · US:71205-979_14464dfb-94a5-43a1-923e-d462b7ade131
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc117120597900100 CAPSULE in 1 BOTTLE (71205-979-00)
- ndc1171205979111000 CAPSULE in 1 BOTTLE (71205-979-11)
- ndc11712059793030 CAPSULE in 1 BOTTLE (71205-979-30)
- ndc117120597955500 CAPSULE in 1 BOTTLE (71205-979-55)
- ndc11712059796060 CAPSULE in 1 BOTTLE (71205-979-60)
- ndc117120597972120 CAPSULE in 1 BOTTLE (71205-979-72)
- ndc11712059799090 CAPSULE in 1 BOTTLE (71205-979-90)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A204597
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": "71205-979_14464dfb-94a5-43a1-923e-d462b7ade131",
"productndc": "71205-979",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204597",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Mar 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Mar 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Mar 16, 2015"
}
],
"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": "ANDA204597",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20190925",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AB03.
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