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United States · US · US:71335-2020_c282532b-eca5-434b-8101-34f75853cc3b
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 · 9
- ndc11713352020130 CAPSULE in 1 BOTTLE (71335-2020-1)
- ndc117133520202100 CAPSULE in 1 BOTTLE (71335-2020-2)
- ndc11713352020360 CAPSULE in 1 BOTTLE (71335-2020-3)
- ndc11713352020415 CAPSULE in 1 BOTTLE (71335-2020-4)
- ndc11713352020556 CAPSULE in 1 BOTTLE (71335-2020-5)
- ndc11713352020628 CAPSULE in 1 BOTTLE (71335-2020-6)
- ndc11713352020790 CAPSULE in 1 BOTTLE (71335-2020-7)
- ndc117133520208120 CAPSULE in 1 BOTTLE (71335-2020-8)
- ndc11713352020945 CAPSULE in 1 BOTTLE (71335-2020-9)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A204597
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": "71335-2020_c282532b-eca5-434b-8101-34f75853cc3b",
"productndc": "71335-2020",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204597",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Mar 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Mar 16, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Mar 16, 2015"
}
],
"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": "ANDA204597",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20150316",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB03.
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