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United States · US · US:71205-178_42459f16-bf6e-409e-b69c-20011d31a64d
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 · 3
- ndc11712051783030 CAPSULE in 1 BOTTLE (71205-178-30)
- ndc11712051786060 CAPSULE in 1 BOTTLE (71205-178-60)
- ndc11712051789090 CAPSULE in 1 BOTTLE (71205-178-90)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A076001
AB1AB1
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": "71205-178_42459f16-bf6e-409e-b69c-20011d31a64d",
"productndc": "71205-178",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "076001",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jan 29, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Jan 29, 2002"
}
],
"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": "ANDA076001",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine",
"start_marketing_date": "20020129",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB03.
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