🇺🇸
United States · US · US:0049-4900_842b5b3f-e0f0-4a16-bb47-2750a605452c
Zoloft
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerROERIG
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11004949003030 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30)
- ndc110049490041100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
N019839
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": {
"fda754f6-d0f3-4dce-a17a-927d64f912f7": {
"match": "brand_token",
"title": "ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [VIATRIS SPECIALTY LLC]",
"spl_version": "7",
"published_date": "2025-07-24"
}
},
"productid": "0049-4900_842b5b3f-e0f0-4a16-bb47-2750a605452c",
"productndc": "0049-4900",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "019839",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Dec 30, 1991"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Dec 30, 1991"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "003",
"approval_date": "Dec 30, 1991"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "004",
"approval_date": "Dec 30, 1991"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "005",
"approval_date": "Mar 6, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTRALINE HYDROCHLORIDE",
"proprietary_name": "Zoloft",
"active_ingred_unit": "mg/1",
"application_number": "NDA019839",
"marketing_category": "NDA",
"nonproprietary_name": "sertraline hydrochloride",
"start_marketing_date": "19920211",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N06AB06.
Access this data programmatically
Query Zoloft 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.