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United States · US · US:63629-1609_6aceb68e-92a2-4e39-b95b-569d30c70ce3
Fluoxetine
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11636291609130 CAPSULE in 1 BOTTLE (63629-1609-1)
- ndc11636291609290 CAPSULE in 1 BOTTLE (63629-1609-2)
- ndc11636291609360 CAPSULE in 1 BOTTLE (63629-1609-3)
- ndc116362916094120 CAPSULE in 1 BOTTLE (63629-1609-4)
- ndc11636291609528 CAPSULE in 1 BOTTLE (63629-1609-5)
- ndc11636291609615 CAPSULE in 1 BOTTLE (63629-1609-6)
- ndc116362916097100 CAPSULE in 1 BOTTLE (63629-1609-7)
- ndc116362916098180 CAPSULE in 1 BOTTLE (63629-1609-8)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A078619
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": "63629-1609_6aceb68e-92a2-4e39-b95b-569d30c70ce3",
"productndc": "63629-1609",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078619",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Jan 31, 2008"
}
],
"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": "ANDA078619",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20080131",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AB03.
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