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United States · US · US:43598-893_10b34299-d60a-f785-70d6-2e5cc344638c

Nitroglycerin Transdermal Infusion System

In shortageOrange BookUNIISPLATC C01DA52

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

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
    4359889330
    30 POUCH in 1 BOX, UNIT-DOSE (43598-893-30) / 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": "43598-893_10b34299-d60a-f785-70d6-2e5cc344638c",
  "productndc": "43598-893",
  "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": "120"
}

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