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United States · US · US:64980-409_eccbd1a5-caba-4b22-b964-95ccb8dadeac
Sertraline Hydrochloride
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164980409061 BOTTLE, PLASTIC in 1 CARTON (64980-409-06) / 60 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A078861
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": {
"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": "64980-409_eccbd1a5-caba-4b22-b964-95ccb8dadeac",
"productndc": "64980-409",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "078861",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 20MG BASE/ML",
"product_no": "001",
"approval_date": "Oct 31, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SERTRALINE HYDROCHLORIDE",
"proprietary_name": "Sertraline Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078861",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline Hydrochloride",
"start_marketing_date": "20081031",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB06.
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