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United States · US · US:0574-0150_d7b8dd9f-1acd-4d10-afbf-a57a93154a6b

Midazolam Hydrochloride

In shortageOrange BookUNIISPLATC N05CD08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeN05CD08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0574015004
    1 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
W7TTW573JJ
MIDAZOLAM HYDROCHLORIDE
RxCUI 203128
Orange Book
A076379
AA
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": "ORAL",
  "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": "0574-0150_d7b8dd9f-1acd-4d10-afbf-a57a93154a6b",
  "productndc": "0574-0150",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "076379",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 2MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 2, 2005"
      }
    ],
    "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": "ANDA076379",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Midazolam Hydrochloride",
  "start_marketing_date": "20050502",
  "active_numerator_strength": "2"
}

Related drugs

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