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United States · US · US:69238-2789_8d3cc874-a2eb-4977-862b-b09fdf66992a
Sertraline HCl
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11692382789130 CAPSULE in 1 BOTTLE (69238-2789-1)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A219655
ABAB
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": "69238-2789_8d3cc874-a2eb-4977-862b-b09fdf66992a",
"productndc": "69238-2789",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "219655",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Jan 28, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "002",
"approval_date": "Jan 28, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTRALINE HYDROCHLORIDE",
"proprietary_name": "Sertraline HCl",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219655",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline",
"start_marketing_date": "20260202",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code N06AB06.
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