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United States · US · US:71335-2587_ff5e2ec3-86b9-4cd1-928b-cea8b012c68f
Sertraline hydrochloride
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11713352587130 TABLET, FILM COATED in 1 BOTTLE (71335-2587-1)
- ndc11713352587260 TABLET, FILM COATED in 1 BOTTLE (71335-2587-2)
- ndc11713352587390 TABLET, FILM COATED in 1 BOTTLE (71335-2587-3)
- ndc117133525874180 TABLET, FILM COATED in 1 BOTTLE (71335-2587-4)
- ndc11713352587528 TABLET, FILM COATED in 1 BOTTLE (71335-2587-5)
- ndc117133525876120 TABLET, FILM COATED in 1 BOTTLE (71335-2587-6)
- ndc117133525877100 TABLET, FILM COATED in 1 BOTTLE (71335-2587-7)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A078403
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": "71335-2587_ff5e2ec3-86b9-4cd1-928b-cea8b012c68f",
"productndc": "71335-2587",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078403",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Jan 8, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Jan 8, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Jan 8, 2008"
}
],
"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": "ANDA078403",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline hydrochloride",
"start_marketing_date": "20230515",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N06AB06.
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