SERTRALINE HYDROCHLORIDE

Orange BookUNIISPLATC N06AB06

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN06AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7133504151
30 TABLET, FILM COATED in 1 BOTTLE (71335-0415-1)
ndc11
7133504152
60 TABLET, FILM COATED in 1 BOTTLE (71335-0415-2)
ndc11
7133504153
90 TABLET, FILM COATED in 1 BOTTLE (71335-0415-3)
ndc11
7133504154
180 TABLET, FILM COATED in 1 BOTTLE (71335-0415-4)
ndc11
7133504155
100 TABLET, FILM COATED in 1 BOTTLE (71335-0415-5)
ndc11
7133504156
56 TABLET, FILM COATED in 1 BOTTLE (71335-0415-6)
ndc11
7133504157
28 TABLET, FILM COATED in 1 BOTTLE (71335-0415-7)
ndc11
7133504158
120 TABLET, FILM COATED in 1 BOTTLE (71335-0415-8)
ndc11
7133504159
15 TABLET, FILM COATED in 1 BOTTLE (71335-0415-9)

Annotations

UNII (FDA Substance ID)

UTI8907Y6X

SERTRALINE HYDROCHLORIDE

RxCUI 155137

Orange Book

A202825

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": "71335-0415_b77be777-f7b7-4f83-ad5e-2dca97a8b2a2",
  "productndc": "71335-0415",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202825",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Nov 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Nov 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Nov 7, 2014"
      }
    ],
    "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": "ANDA202825",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SERTRALINE HYDROCHLORIDE",
  "start_marketing_date": "20170209",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N06AB06.

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