🇺🇸
United States · US · US:16714-114_e90468ef-aee3-2684-3a9d-7bd58919e9de
Fluoxetine hydrochloride
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11167141140130 TABLET, FILM COATED in 1 BOTTLE (16714-114-01)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A211721
AB
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; 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": "16714-114_e90468ef-aee3-2684-3a9d-7bd58919e9de",
"productndc": "16714-114",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211721",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 60MG BASE",
"product_no": "001",
"approval_date": "Jan 25, 2019"
}
],
"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": "ANDA211721",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine hydrochloride",
"start_marketing_date": "20190918",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N06AB03.
Access this data programmatically
Query Fluoxetine hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.