Nitrostat

In shortageOrange BookUNIISPLATC C01DA52

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeC01DA52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5815131101
1 BOTTLE in 1 CARTON (58151-311-01) / 100 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

G59M7S0WS3

NITROGLYCERIN

RxCUI 4917

Orange Book

N021134

ABABAB

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": "SUBLINGUAL",
  "spl_meta": {
    "5265648f-3062-48a2-a4e3-fea1207807a8": {
      "match": "brand_token",
      "title": "NITROSTAT (NITROGLYCERIN TABLET) TABLET [HENRY SCHEIN, INC.]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "58151-311_793962da-82d4-4fe1-b78d-dccf10a8ff85",
  "productndc": "58151-311",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021134",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.3MG",
        "product_no": "001",
        "approval_date": "May 1, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.4MG",
        "product_no": "002",
        "approval_date": "May 1, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.6MG",
        "product_no": "003",
        "approval_date": "May 1, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITROGLYCERIN",
  "shortage_reason": "Nitroglycerin Ointment",
  "shortage_status": "current",
  "proprietary_name": "Nitrostat",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021134",
  "marketing_category": "NDA",
  "nonproprietary_name": "nitroglycerin",
  "start_marketing_date": "20240209",
  "active_numerator_strength": ".6"
}

Related drugs

Other records sharing ATC code C01DA52.

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