Sertraline Hydrochloride

Orange BookUNIISPLATC N06AB06

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6878868351
100 TABLET, FILM COATED in 1 BOTTLE (68788-6835-1)
ndc11
6878868352
28 TABLET, FILM COATED in 1 BOTTLE (68788-6835-2)
ndc11
6878868353
30 TABLET, FILM COATED in 1 BOTTLE (68788-6835-3)
ndc11
6878868356
60 TABLET, FILM COATED in 1 BOTTLE (68788-6835-6)
ndc11
6878868358
120 TABLET, FILM COATED in 1 BOTTLE (68788-6835-8)
ndc11
6878868359
90 TABLET, FILM COATED in 1 BOTTLE (68788-6835-9)

Annotations

UNII (FDA Substance ID)

UTI8907Y6X

SERTRALINE HYDROCHLORIDE

RxCUI 155137

Orange Book

A077206

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": "68788-6835_1a6f3793-c507-4d36-85da-0c482e695c6b",
  "productndc": "68788-6835",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077206",
    "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": "ANDA077206",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sertraline Hydrochloride",
  "start_marketing_date": "20161121",
  "active_numerator_strength": "100"
}

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