Nitroglycerin Transdermal Infusion System

In shortageOrange BookUNIISPLATC C01DA52

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

Identification

ManufacturerDr. Reddy's Laboratories, Inc.

CountryUS (United States)

ATC codeC01DA52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359889530
30 POUCH in 1 BOX, UNIT-DOSE (43598-895-30) / 1 PATCH in 1 POUCH

Annotations

UNII (FDA Substance ID)

G59M7S0WS3

NITROGLYCERIN

RxCUI 4917

Orange Book

N020145

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Nitroglycerin Ointment

Raw payload (JSON)

{
  "unii": {
    "unii": "G59M7S0WS3",
    "rxcui": "4917",
    "inchikey": "SNIOPGDIGTZGOP-UHFFFAOYSA-N",
    "display_name": "NITROGLYCERIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "7cf08521-aaf6-4129-9f8e-077d6282fbc6": {
      "match": "brand_token",
      "title": "NITROGLYCERIN OINTMENT [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2026-05-20"
    }
  },
  "productid": "43598-895_10b34299-d60a-f785-70d6-2e5cc344638c",
  "productndc": "43598-895",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "020145",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.1MG/HR",
        "product_no": "001",
        "approval_date": "Apr 4, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/HR",
        "product_no": "002",
        "approval_date": "Apr 4, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.3MG/HR",
        "product_no": "003",
        "approval_date": "Apr 4, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG/HR",
        "product_no": "004",
        "approval_date": "Apr 4, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.6MG/HR",
        "product_no": "005",
        "approval_date": "Apr 4, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.8MG/HR",
        "product_no": "006",
        "approval_date": "Apr 4, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROGLYCERIN",
  "shortage_reason": "Nitroglycerin Ointment",
  "shortage_status": "current",
  "proprietary_name": "Nitroglycerin Transdermal Infusion System",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020145",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Nitroglycerin",
  "start_marketing_date": "20200301",
  "active_numerator_strength": "40"
}

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