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United States · US · US:49884-335_71c75730-de24-4bfe-ad24-c92107cd5b74
fluoxetine hydrochloride
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114988433501100 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-01)
- ndc11498843351130 TABLET, COATED in 1 BOTTLE, PLASTIC (49884-335-11)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A203836
ABAB
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": "49884-335_71c75730-de24-4bfe-ad24-c92107cd5b74",
"productndc": "49884-335",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "203836",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Aug 19, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Aug 19, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOXETINE HYDROCHLORIDE",
"proprietary_name": "fluoxetine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203836",
"marketing_category": "ANDA",
"nonproprietary_name": "fluoxetine hydrochloride",
"start_marketing_date": "20160822",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AB03.
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