Nayzilam

In shortageOrange BookUNIIATC N05CD08

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

Identification

ManufacturerUCB, Inc.

CountryUS (United States)

ATC codeN05CD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5047450015
2 BLISTER PACK in 1 CARTON (50474-500-15) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (50474-500-14) / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

R60L0SM5BC

MIDAZOLAM

RxCUI 6960

Orange Book

N211321

FDA shortage

Currently in shortage

Midazolam Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "R60L0SM5BC",
    "rxcui": "6960",
    "inchikey": "DDLIGBOFAVUZHB-UHFFFAOYSA-N",
    "display_name": "MIDAZOLAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "productid": "50474-500_5776d86f-c632-429f-ac0b-88ade1a3930c",
  "productndc": "50474-500",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "211321",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG/SPRAY",
        "product_no": "001",
        "approval_date": "May 17, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIDAZOLAM",
  "shortage_reason": "Midazolam Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Nayzilam",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA211321",
  "marketing_category": "NDA",
  "nonproprietary_name": "midazolam",
  "start_marketing_date": "20190517",
  "active_numerator_strength": "5"
}

Related drugs

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