SERTRALINE

Orange BookUNIISPLATC N06AB06

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN06AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7161081815
15 TABLET, FILM COATED in 1 BOTTLE (71610-818-15)
ndc11
7161081830
30 TABLET, FILM COATED in 1 BOTTLE (71610-818-30)
ndc11
7161081845
45 TABLET, FILM COATED in 1 BOTTLE (71610-818-45)
ndc11
7161081860
90 TABLET, FILM COATED in 1 BOTTLE (71610-818-60)

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": "71610-818_3a7784f8-edc2-8cb2-e063-6294a90a8cdc",
  "productndc": "71610-818",
  "dosage_form": "TABLET, FILM COATED",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077397",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sertraline",
  "start_marketing_date": "20120820",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N06AB06.

Access this data programmatically

Query SERTRALINE 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