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United States · US · US:64380-900_adcbffe8-9a0c-421a-9a18-21faac0207eb
FLUOXETINE HCL
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11643809000430 TABLET in 1 BOTTLE (64380-900-04)
Annotations
UNII (FDA Substance ID)
01K63SUP8D
FLUOXETINE
RxCUI 4493
Orange Book
A212683
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "01K63SUP8D",
"rxcui": "4493",
"inchikey": "RTHCYVBBDHJXIQ-UHFFFAOYSA-N",
"display_name": "FLUOXETINE",
"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": "64380-900_adcbffe8-9a0c-421a-9a18-21faac0207eb",
"productndc": "64380-900",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212683",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 60MG BASE",
"product_no": "001",
"approval_date": "Sep 13, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOXETINE",
"proprietary_name": "FLUOXETINE HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212683",
"marketing_category": "ANDA",
"nonproprietary_name": "fluoxetine hcl",
"start_marketing_date": "20241108",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N06AB03.
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