Midazolam In Sodium Chloride

In shortageOrange BookUNIISPLATC N05CD08

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

Identification

ManufacturerFRESENIUS KABI USA, LLC

CountryUS (United States)

ATC codeN05CD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6521965010
10 POUCH in 1 CARTON (65219-650-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
ndc11
6521965050
10 POUCH in 1 CARTON (65219-650-50) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

W7TTW573JJ

MIDAZOLAM HYDROCHLORIDE

RxCUI 203128

Orange Book

A218993

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Midazolam Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "W7TTW573JJ",
    "rxcui": "203128",
    "inchikey": "PLYSCVSCYOQVRP-UHFFFAOYSA-N",
    "display_name": "MIDAZOLAM HYDROCHLORIDE",
    "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": "65219-650_a43f63a4-8a7f-4a1b-b9a0-4198486cfef6",
  "productndc": "65219-650",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218993",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/50ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/100ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Aug 12, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIDAZOLAM HYDROCHLORIDE",
  "shortage_reason": "Midazolam Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Midazolam In Sodium Chloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218993",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Midazolam In Sodium Chloride",
  "start_marketing_date": "20250115",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05CD08.

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