Midazolam Hydrochloride

In shortageOrange BookUNIISPLATC N05CD08

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN05CD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009054720
10 VIAL in 1 BOX (50090-5472-0) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

W7TTW573JJ

MIDAZOLAM HYDROCHLORIDE

RxCUI 203128

Orange Book

A075293

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": "INTRAMUSCULAR; 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": "50090-5472_cb0416fe-b4c5-4935-b6b7-d3cf1d276f18",
  "productndc": "50090-5472",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "075293",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jun 20, 2000"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "002",
        "approval_date": "Jun 20, 2000"
      }
    ],
    "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 Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075293",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MIDAZOLAM HYDROCHLORIDE",
  "start_marketing_date": "20060202",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05CD08.

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