🇺🇸
United States · US · US:16729-215_46293a9f-fad8-a06b-e063-6294a90acb9a
SERTRALINE HYDROCHLORIDE
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare, Inc.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11167292151030 TABLET, FILM COATED in 1 BOTTLE (16729-215-10)
- ndc11167292151590 TABLET, FILM COATED in 1 BOTTLE (16729-215-15)
- ndc111672921516500 TABLET, FILM COATED in 1 BOTTLE (16729-215-16)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A202825
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": "16729-215_46293a9f-fad8-a06b-e063-6294a90acb9a",
"productndc": "16729-215",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202825",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "Nov 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "Nov 7, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Nov 7, 2014"
}
],
"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": "ANDA202825",
"marketing_category": "ANDA",
"nonproprietary_name": "SERTRALINE HYDROCHLORIDE",
"start_marketing_date": "20170209",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N06AB06.
Access this data programmatically
Query SERTRALINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.