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United States · US · US:63187-884_3195d486-86b4-4ee4-b049-a1ad55e9ab06

Nitrostat

In shortageOrange BookUNIISPLATC C01DA52

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC01DA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6318788425
    25 TABLET in 1 BOTTLE (63187-884-25)

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": "63187-884_3195d486-86b4-4ee4-b049-a1ad55e9ab06",
  "productndc": "63187-884",
  "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": "20000501",
  "active_numerator_strength": ".4"
}

Related drugs

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