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United States · US · US:0777-3107_e49a90e3-e7da-4377-8736-ebe9f53c3097
Prozac
Orange BookUNIISPLATC N06AB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDista Products Company
CountryUS (United States)
ATC codeN06AB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11077731073030 CAPSULE in 1 BOTTLE (0777-3107-30)
Annotations
UNII (FDA Substance ID)
I9W7N6B1KJ
FLUOXETINE HYDROCHLORIDE
RxCUI 227224
Orange Book
N018936
AB1ABAB1
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": {
"c88f33ed-6dfb-4c5e-bc01-d8e36dd97299": {
"match": "brand_token",
"title": "PROZAC (FLUOXETINE HYDROCHLORIDE) CAPSULE [DISTA PRODUCTS COMPANY]",
"spl_version": "59",
"published_date": "2026-01-14"
}
},
"productid": "0777-3107_e49a90e3-e7da-4377-8736-ebe9f53c3097",
"productndc": "0777-3107",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "018936",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB1",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Dec 29, 1987"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Jun 15, 1999"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "004",
"approval_date": "Jun 15, 1999"
},
{
"rs": false,
"rld": true,
"te_code": "AB1",
"strength": "EQ 10MG BASE",
"product_no": "006",
"approval_date": "Dec 23, 1992"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "007",
"approval_date": "Jul 6, 2000"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "008",
"approval_date": "Jul 6, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOXETINE HYDROCHLORIDE",
"proprietary_name": "Prozac",
"active_ingred_unit": "mg/1",
"application_number": "NDA018936",
"marketing_category": "NDA",
"nonproprietary_name": "Fluoxetine hydrochloride",
"start_marketing_date": "19990615",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AB03.
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