🇺🇸
United States · US · US:43602-980_91447af3-b3d6-4ffe-8c89-1869a22373ba
SERTRALINE HYDROCHLORIDE
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscent Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11436029801530 TABLET in 1 BOTTLE (43602-980-15)
- ndc114360298016500 TABLET in 1 BOTTLE (43602-980-16)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A214790
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": "43602-980_91447af3-b3d6-4ffe-8c89-1869a22373ba",
"productndc": "43602-980",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214790",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "001",
"approval_date": "May 3, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "002",
"approval_date": "May 3, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "May 3, 2021"
}
],
"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": "ANDA214790",
"marketing_category": "ANDA",
"nonproprietary_name": "sertraline hydrochloride",
"start_marketing_date": "20210503",
"active_numerator_strength": "50"
}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.