Sertraline Hydrochloride

Orange BookUNIISPLATC N06AB06

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

Identification

ManufacturerLegacy Pharmaceutical Packaging, LLC

CountryUS (United States)

ATC codeN06AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6864552254
30 TABLET in 1 BOTTLE (68645-522-54)

Annotations

UNII (FDA Substance ID)

UTI8907Y6X

SERTRALINE HYDROCHLORIDE

RxCUI 155137

Orange Book

A077397

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": "68645-522_4cc29310-2a31-9e2e-e063-6294a90a8e5d",
  "productndc": "68645-522",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077397",
    "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": "ANDA077397",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sertraline Hydrochloride",
  "start_marketing_date": "20160721",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N06AB06.

Access this data programmatically

Query Sertraline Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs