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United States · US · US:0049-0050_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 · 1
- ndc1100490050011 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
N020990
AA
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": "0049-0050_842b5b3f-e0f0-4a16-bb47-2750a605452c",
"productndc": "0049-0050",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "020990",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "EQ 20MG BASE/ML",
"product_no": "001",
"approval_date": "Dec 7, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTRALINE HYDROCHLORIDE",
"proprietary_name": "Zoloft",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020990",
"marketing_category": "NDA",
"nonproprietary_name": "sertraline hydrochloride",
"start_marketing_date": "20170106",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB06.
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