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United States · US · US:71335-2587_ff5e2ec3-86b9-4cd1-928b-cea8b012c68f

Sertraline hydrochloride

Orange BookUNIISPLATC N06AB06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AB06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7133525871
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2587-1)
  • ndc11
    7133525872
    60 TABLET, FILM COATED in 1 BOTTLE (71335-2587-2)
  • ndc11
    7133525873
    90 TABLET, FILM COATED in 1 BOTTLE (71335-2587-3)
  • ndc11
    7133525874
    180 TABLET, FILM COATED in 1 BOTTLE (71335-2587-4)
  • ndc11
    7133525875
    28 TABLET, FILM COATED in 1 BOTTLE (71335-2587-5)
  • ndc11
    7133525876
    120 TABLET, FILM COATED in 1 BOTTLE (71335-2587-6)
  • ndc11
    7133525877
    100 TABLET, FILM COATED in 1 BOTTLE (71335-2587-7)

Annotations

UNII (FDA Substance ID)
UTI8907Y6X
SERTRALINE HYDROCHLORIDE
RxCUI 155137
Orange Book
A078403
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": "71335-2587_ff5e2ec3-86b9-4cd1-928b-cea8b012c68f",
  "productndc": "71335-2587",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078403",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Jan 8, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Jan 8, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Jan 8, 2008"
      }
    ],
    "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": "ANDA078403",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sertraline hydrochloride",
  "start_marketing_date": "20230515",
  "active_numerator_strength": "25"
}

Related drugs

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