Sertraline Hydrochloride

Orange BookUNIISPLATC N06AB06

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN06AB06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8438609901
100 TABLET, FILM COATED in 1 BOTTLE (84386-099-01)
ndc11
8438609905
500 TABLET, FILM COATED in 1 BOTTLE (84386-099-05)
ndc11
8438609925
2500 TABLET, FILM COATED in 1 BOTTLE (84386-099-25)
ndc11
8438609930
30 TABLET, FILM COATED in 1 BOTTLE (84386-099-30)
ndc11
8438609950
50 TABLET, FILM COATED in 1 BOTTLE (84386-099-50)
ndc11
8438609960
60 TABLET, FILM COATED in 1 BOTTLE (84386-099-60)
ndc11
8438609990
90 TABLET, FILM COATED in 1 BOTTLE (84386-099-90)
ndc11
8438609999
1000 TABLET, FILM COATED in 1 BOTTLE (84386-099-99)

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": "84386-099_b497dfeb-a48c-4f2a-b309-b56f3a26a19b",
  "productndc": "84386-099",
  "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": "20251120",
  "active_numerator_strength": "100"
}

Related drugs

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