NITROSTAT

In shortageOrange BookUNIISPLATC C01DA52

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC01DA52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009072030
1 BOTTLE in 1 CARTON (50090-7203-0) / 25 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": "50090-7203_d66cce9b-74ee-43e0-9e2e-e485be38209e",
  "productndc": "50090-7203",
  "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": "20240202",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code C01DA52.

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