Perphenazine and Amitriptyline Hydrochloride

Orange BookUNIISPLATC N06AA

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378007301
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0073-01)

Annotations

UNII (FDA Substance ID)

26LUD4JO9K

AMITRIPTYLINE HYDROCHLORIDE

RxCUI 203168

Orange Book

A071443

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "26LUD4JO9K",
    "rxcui": "203168",
    "inchikey": "KFYRPLNVJVHZGT-UHFFFAOYSA-N",
    "display_name": "AMITRIPTYLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bb08cedf-18ab-4341-a84e-c092ff7a5c98": {
      "match": "brand_token",
      "title": "PERPHENAZINE TABLET [REMEDYREPACK INC.]",
      "spl_version": "3",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0378-0073_a0ce12cc-6720-4bbe-9e86-41feb8e6d4cd",
  "productndc": "0378-0073",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "071443",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "50MG;4MG",
        "product_no": "001",
        "approval_date": "Nov 10, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;2MG",
        "product_no": "002",
        "approval_date": "Nov 10, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;4MG",
        "product_no": "003",
        "approval_date": "Nov 10, 1988"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "25MG;2MG",
        "product_no": "004",
        "approval_date": "Nov 10, 1988"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "25MG;4MG",
        "product_no": "005",
        "approval_date": "Nov 10, 1988"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE",
  "proprietary_name": "Perphenazine and Amitriptyline Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA071443",
  "marketing_category": "ANDA",
  "nonproprietary_name": "perphenazine and amitriptyline hydrochloride",
  "start_marketing_date": "19881110",
  "active_numerator_strength": "50; 4"
}

Related drugs

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