Midazolam

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 · 4

ndc11
6332341110
10 VIAL in 1 TRAY (63323-411-10) / 10 mL in 1 VIAL (63323-411-13)
ndc11
6332341112
25 VIAL in 1 TRAY (63323-411-12) / 2 mL in 1 VIAL (63323-411-15)
ndc11
6332341125
25 VIAL in 1 TRAY (63323-411-25) / 5 mL in 1 VIAL (63323-411-18)
ndc11
6332341127
25 VIAL in 1 TRAY (63323-411-27) / 2 mL in 1 VIAL (63323-411-22)

Annotations

UNII (FDA Substance ID)

W7TTW573JJ

MIDAZOLAM HYDROCHLORIDE

RxCUI 203128

Orange Book

A075154

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": "63323-411_9814447b-a93e-42ad-b57e-5db0a5b7f552",
  "productndc": "63323-411",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "075154",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jun 20, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG 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",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075154",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MIDAZOLAM HYDROCHLORIDE",
  "start_marketing_date": "20000714",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N05CD08.

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