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United States · US · US:62332-023_88b2df81-f3ba-4455-8dc5-8fd2eb4929f3
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11623320233030 CAPSULE in 1 BOTTLE (62332-023-30)
- ndc116233202331100 CAPSULE in 1 BOTTLE (62332-023-31)
- ndc1162332023911000 CAPSULE in 1 BOTTLE (62332-023-91)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A090223
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": "62332-023_88b2df81-f3ba-4455-8dc5-8fd2eb4929f3",
"productndc": "62332-023",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090223",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Mar 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Mar 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Mar 19, 2009"
}
],
"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": "ANDA090223",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine",
"start_marketing_date": "20160129",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB03.
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