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United States · US · US:58151-601_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 · 1

  • ndc11
    5815160135
    1 BOTTLE, DROPPER in 1 CARTON (58151-601-35) / 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": "58151-601_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a",
  "productndc": "58151-601",
  "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": "20241121",
  "active_numerator_strength": "20"
}

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