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United States · US · US:0409-1176_c1704eaf-f0a8-4ba3-89a1-2836ba7e5ee6

DEMEROL

In shortageOrange BookUNIISPLATC N02AB52

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeN02AB52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409117630
    10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03)

Annotations

UNII (FDA Substance ID)
N8E7F7Q170
MEPERIDINE HYDROCHLORIDE
RxCUI 103755
Orange Book
N021171
APAPAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Meperidine Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "N8E7F7Q170",
    "rxcui": "103755",
    "inchikey": "WCNLCIJMFAJCPX-UHFFFAOYSA-N",
    "display_name": "MEPERIDINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "b31d1308-28c3-43f4-e0a6-2f3ed76b8975": {
      "match": "brand_token",
      "title": "DEMEROL (MEPERIDINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "37",
      "published_date": "2026-01-01"
    }
  },
  "productid": "0409-1176_c1704eaf-f0a8-4ba3-89a1-2836ba7e5ee6",
  "productndc": "0409-1176",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021171",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "75MG/ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEPERIDINE HYDROCHLORIDE",
  "shortage_reason": "Meperidine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "DEMEROL",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021171",
  "marketing_category": "NDA",
  "nonproprietary_name": "MEPERIDINE HYDROCHLORIDE",
  "start_marketing_date": "20050825",
  "active_numerator_strength": "25"
}

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