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United States · US · US:68788-8618_ec67d3fd-5f16-4fc1-b174-90ede65171a0
FLUOXETINE
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116878886181100 CAPSULE in 1 BOTTLE (68788-8618-1)
- ndc11687888618330 CAPSULE in 1 BOTTLE (68788-8618-3)
- ndc11687888618690 CAPSULE in 1 BOTTLE (68788-8618-6)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A201336
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": "68788-8618_ec67d3fd-5f16-4fc1-b174-90ede65171a0",
"productndc": "68788-8618",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "201336",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Oct 1, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Oct 1, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Oct 1, 2012"
}
],
"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": "ANDA201336",
"marketing_category": "ANDA",
"nonproprietary_name": "FLUOXETINE",
"start_marketing_date": "20240328",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AB03.
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