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United States · US · US:82009-049_8ebb7a30-d0c9-4604-b4ec-7fb3bba6cade
Sertraline Hydrochloride
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQuallent Pharmaceuticals Health LLC
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118200904905500 TABLET, FILM COATED in 1 BOTTLE (82009-049-05)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A077397
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": "82009-049_8ebb7a30-d0c9-4604-b4ec-7fb3bba6cade",
"productndc": "82009-049",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077397",
"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": "ANDA077397",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline Hydrochloride",
"start_marketing_date": "20230928",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N06AB06.
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