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United States · US · US:76282-213_5c34aa64-3f25-4d6e-8fbb-98aa3688f72d
SERTRALINE
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExelan Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117628221301100 TABLET, FILM COATED in 1 BOTTLE (76282-213-01)
- ndc117628221305500 TABLET, FILM COATED in 1 BOTTLE (76282-213-05)
- ndc117628221318180 TABLET, FILM COATED in 1 BOTTLE (76282-213-18)
- ndc11762822133030 TABLET, FILM COATED in 1 BOTTLE (76282-213-30)
- ndc11762822136060 TABLET, FILM COATED in 1 BOTTLE (76282-213-60)
- ndc11762822139090 TABLET, FILM COATED in 1 BOTTLE (76282-213-90)
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": "76282-213_5c34aa64-3f25-4d6e-8fbb-98aa3688f72d",
"productndc": "76282-213",
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077397",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline",
"start_marketing_date": "20120820",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N06AB06.
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