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United States · US · US:47781-951_6dc518cc-d3cf-5888-2b4e-90d598afac58
sertraline hydrochloride
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlvogen, Inc.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11477819513030 CAPSULE in 1 BOTTLE (47781-951-30)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
N215133
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": "47781-951_6dc518cc-d3cf-5888-2b4e-90d598afac58",
"productndc": "47781-951",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215133",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Oct 4, 2021"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 200MG BASE",
"product_no": "002",
"approval_date": "Oct 4, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTRALINE HYDROCHLORIDE",
"proprietary_name": "sertraline hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "NDA215133",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "sertraline hydrochloride",
"start_marketing_date": "20250918",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code N06AB06.
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