Midazolam

In shortageOrange BookUNIISPLATC N05CD08

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

Identification

ManufacturerSOMERSET THERAPEUTICS, LLC

CountryUS (United States)

ATC codeN05CD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7006981610
10 VIAL in 1 CARTON (70069-816-10) / 2 mL in 1 VIAL
ndc11
7006981625
25 VIAL in 1 CARTON (70069-816-25) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

W7TTW573JJ

MIDAZOLAM HYDROCHLORIDE

RxCUI 203128

Orange Book

A090315

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": "70069-816_0bbe4e90-4c26-cbbb-e063-6294a90aad1b",
  "productndc": "70069-816",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090315",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Nov 29, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "002",
        "approval_date": "Nov 29, 2010"
      }
    ],
    "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/2mL",
  "application_number": "ANDA090315",
  "marketing_category": "ANDA",
  "nonproprietary_name": "midazolam hydrochloride",
  "start_marketing_date": "20231205",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N05CD08.

Access this data programmatically

Query Midazolam and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs