Midazolam

In shortageOrange BookUNIISPLATC N05CD08

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN05CD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641621810
10 SYRINGE in 1 CARTON (0641-6218-10) / 1 mL in 1 SYRINGE (0641-6218-01)

Annotations

UNII (FDA Substance ID)

W7TTW573JJ

MIDAZOLAM HYDROCHLORIDE

RxCUI 203128

Orange Book

A212847

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": "0641-6218_c7078d4a-0f37-4305-b20c-0a8f17382963",
  "productndc": "0641-6218",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212847",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Dec 11, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "002",
        "approval_date": "Dec 11, 2020"
      }
    ],
    "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": "ANDA212847",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Midazolam",
  "start_marketing_date": "20240329",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N05CD08.

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