MIDAZOLAM IN 0.8% SODIUM CHLORIDE

In shortageOrange BookUNIISPLATC N05CD08

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

Identification

ManufacturerB. Braun Medical Inc.

CountryUS (United States)

ATC codeN05CD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0264800531
40 CONTAINER in 1 CASE (0264-8005-31) / 50 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

R60L0SM5BC

MIDAZOLAM

RxCUI 6960

Orange Book

A218454

DailyMed SPL labels

1 version tracked

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": "INTRAVENOUS",
  "spl_meta": {
    "8b690f5c-2923-4c34-a8f7-11af5f546b62": {
      "match": "brand_token",
      "title": "MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "13",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0264-8005_1287da80-6b0a-4ba3-b698-d1dc0e78c294",
  "productndc": "0264-8005",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218454",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "50MG/50ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "May 1, 2025"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG/100ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "May 1, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIDAZOLAM",
  "shortage_reason": "Midazolam Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "MIDAZOLAM IN 0.8% SODIUM CHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218454",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MIDAZOLAM IN 0.8% SODIUM CHLORIDE",
  "start_marketing_date": "20251015",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05CD08.

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