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United States · US · US:68788-6429_c7ed2451-d63a-4d50-a044-27a13a7727ac
Sertraline Hydrochloride
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116878864291100 TABLET, FILM COATED in 1 BOTTLE (68788-6429-1)
- ndc11687886429228 TABLET, FILM COATED in 1 BOTTLE (68788-6429-2)
- ndc11687886429330 TABLET, FILM COATED in 1 BOTTLE (68788-6429-3)
- ndc11687886429660 TABLET, FILM COATED in 1 BOTTLE (68788-6429-6)
- ndc116878864298120 TABLET, FILM COATED in 1 BOTTLE (68788-6429-8)
- ndc11687886429990 TABLET, FILM COATED in 1 BOTTLE (68788-6429-9)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A077206
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UTI8907Y6X",
"rxcui": "155137",
"inchikey": "BLFQGGGGFNSJKA-XHXSRVRCSA-N",
"display_name": "SERTRALINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6c26a87a-b2b6-4302-bb8d-2031461f28ce": {
"match": "brand_token",
"title": "SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-28"
}
},
"productid": "68788-6429_c7ed2451-d63a-4d50-a044-27a13a7727ac",
"productndc": "68788-6429",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077206",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Feb 6, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Feb 6, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Feb 6, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTRALINE HYDROCHLORIDE",
"proprietary_name": "Sertraline Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077206",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline Hydrochloride",
"start_marketing_date": "20160628",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N06AB06.
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