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United States · US · US:0641-6053_9566d54d-7343-4695-94ff-8b5f2d384c81

MEPERIDINE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N02AB52

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

Identification

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

Packs · 1

  • ndc11
    0641605325
    25 VIAL in 1 CARTON (0641-6053-25) / 1 mL in 1 VIAL (0641-6053-01)

Annotations

UNII (FDA Substance ID)
N8E7F7Q170
MEPERIDINE HYDROCHLORIDE
RxCUI 103755
Orange Book
A080445
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": {
    "15bc51a8-1e24-4d33-9a2f-05a41c29acf0": {
      "match": "brand_token",
      "title": "MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "25",
      "published_date": "2026-03-09"
    }
  },
  "productid": "0641-6053_9566d54d-7343-4695-94ff-8b5f2d384c81",
  "productndc": "0641-6053",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "080445",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "75MG/ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEPERIDINE HYDROCHLORIDE",
  "shortage_reason": "Meperidine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "MEPERIDINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA080445",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MEPERIDINE HYDROCHLORIDE",
  "start_marketing_date": "19750122",
  "active_numerator_strength": "50"
}

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