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United States · US · US:58151-575_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a

Zoloft

Orange BookUNIISPLATC N06AB06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN06AB06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5815157588
    100 BLISTER PACK in 1 CARTON (58151-575-88) / 1 TABLET, FILM COATED in 1 BLISTER PACK (58151-575-32)
  • ndc11
    5815157593
    30 TABLET, FILM COATED in 1 BOTTLE (58151-575-93)

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": "58151-575_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a",
  "productndc": "58151-575",
  "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        "strength": "EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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        "strength": "EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "20250708",
  "active_numerator_strength": "50"
}

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