Protriptyline Hydrochloride

Orange BookUNIISPLATC N06AA11

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

Identification

ManufacturerSigmapharm Laboratories, LLC

CountryUS (United States)

ATC codeN06AA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4279400402
100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02)

Annotations

UNII (FDA Substance ID)

44665V00O8

PROTRIPTYLINE HYDROCHLORIDE

RxCUI 203199

Orange Book

A090462

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "44665V00O8",
    "rxcui": "203199",
    "inchikey": "OGQDIIKRQRZXJH-UHFFFAOYSA-N",
    "display_name": "PROTRIPTYLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c6c7c39e-e510-4f4a-bf7a-926f0e075d3a": {
      "match": "brand_token",
      "title": "PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]",
      "spl_version": "10",
      "published_date": "2023-12-21"
    }
  },
  "productid": "42794-004_f1f190da-554e-55cb-e053-2a95a90a2871",
  "productndc": "42794-004",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090462",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 3, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 3, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROTRIPTYLINE HYDROCHLORIDE",
  "proprietary_name": "Protriptyline Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090462",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Protriptyline Hydrochloride",
  "start_marketing_date": "20200302",
  "active_numerator_strength": "5"
}

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