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United States · US · US:70518-4518_50ac571a-82ed-b876-e063-6294a90ae333
Sertraline Hydrochloride
Orange BookUNIISPLATC N06AB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN06AB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11705184518030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4518-0)
- ndc11705184518130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4518-1)
- ndc11705184518230 TABLET, FILM COATED in 1 BLISTER PACK (70518-4518-2)
- ndc11705184518350 POUCH in 1 BOX (70518-4518-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-4518-4)
- ndc11705184518530 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4518-5)
Annotations
UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A077670
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": "70518-4518_50ac571a-82ed-b876-e063-6294a90ae333",
"productndc": "70518-4518",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077670",
"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 Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077670",
"marketing_category": "ANDA",
"nonproprietary_name": "Sertraline Hydrochloride",
"start_marketing_date": "20251110",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N06AB06.
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