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United States · US · US:68180-997_e905b16a-58b6-4211-9931-dd2047db998a
Fluoxetine Hydrochloride
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11681809970630 TABLET in 1 BOTTLE (68180-997-06)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
A211632
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": "68180-997_e905b16a-58b6-4211-9931-dd2047db998a",
"productndc": "68180-997",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211632",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "001",
"approval_date": "Feb 8, 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": "ANDA211632",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluoxetine Hydrochloride",
"start_marketing_date": "20190409",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N06AB03.
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