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United States · US · US:70954-538_8ab1c887-76fb-44ca-9999-4eefd3778cfc

Tranylcypromine

In shortageOrange BookUNIISPLATC N06AF04

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

Identification

ManufacturerNovitium Pharma LLC
CountryUS (United States)
ATC codeN06AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095453810
    100 TABLET in 1 BOTTLE (70954-538-10)

Annotations

UNII (FDA Substance ID)
7ZAT6ES870
TRANYLCYPROMINE SULFATE
RxCUI 91119
Orange Book
A206856
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Tranylcypromine Sulfate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "7ZAT6ES870",
    "rxcui": "91119",
    "inchikey": "BKPRVQDIOGQWTG-KAVFMPKWSA-N;BKPRVQDIOGQWTG-FKXFVUDVSA-N",
    "display_name": "TRANYLCYPROMINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6a0b609b-0625-4c26-91a1-59ee3ece3ddf": {
      "match": "brand_token",
      "title": "TRANYLCYPROMINE SULFATE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]",
      "spl_version": "8",
      "published_date": "2025-07-28"
    }
  },
  "productid": "70954-538_8ab1c887-76fb-44ca-9999-4eefd3778cfc",
  "productndc": "70954-538",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206856",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Apr 17, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRANYLCYPROMINE SULFATE",
  "shortage_reason": "Tranylcypromine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tranylcypromine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206856",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tranylcypromine",
  "start_marketing_date": "20210606",
  "active_numerator_strength": "10"
}

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