Sertraline

Orange BookUNIISPLATC N06AB06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerST. MARY'S MEDICAL PARK PHARMACY

CountryUS (United States)

ATC codeN06AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6076068390
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-683-90)

Annotations

UNII (FDA Substance ID)

UTI8907Y6X

SERTRALINE HYDROCHLORIDE

RxCUI 155137

Orange Book

A076465

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": "60760-683_3dd832b1-cef3-e200-e063-6294a90a8ec3",
  "productndc": "60760-683",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076465",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Aug 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Aug 11, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Aug 11, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SERTRALINE HYDROCHLORIDE",
  "proprietary_name": "Sertraline",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076465",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sertraline",
  "start_marketing_date": "20230223",
  "active_numerator_strength": "50"
}

Related drugs

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