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United States · US · US:23155-758_5079a5d2-af51-4bac-aaad-75653da2aa97
Sertraline
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11231557580330 TABLET, FILM COATED in 1 BOTTLE (23155-758-03)
- ndc112315575805500 TABLET, FILM COATED in 1 BOTTLE (23155-758-05)
- ndc11231557580990 TABLET, FILM COATED in 1 BOTTLE (23155-758-09)
- ndc1123155758695000 TABLET, FILM COATED in 1 BOTTLE (23155-758-69)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A076465
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": "23155-758_5079a5d2-af51-4bac-aaad-75653da2aa97",
"productndc": "23155-758",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076465",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Aug 11, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Aug 11, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Aug 11, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTRALINE HYDROCHLORIDE",
"proprietary_name": "Sertraline",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076465",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline",
"start_marketing_date": "20230223",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N06AB06.
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