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United States · US · US:55111-284_69d11d5f-adf1-142a-b4e2-1bace590eba8
Fluoxetine hydrochloride
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Limited
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155111284481 BLISTER PACK in 1 CARTON (55111-284-48) / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A078572
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": "55111-284_69d11d5f-adf1-142a-b4e2-1bace590eba8",
"productndc": "55111-284",
"dosage_form": "CAPSULE, DELAYED RELEASE PELLETS",
"orange_book": {
"appl_no": "078572",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 90MG BASE",
"product_no": "001",
"approval_date": "Mar 22, 2010"
}
],
"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": "ANDA078572",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20100324",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code N06AB03.
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