ketamine hydrochloride

In shortageOrange BookUNIISPLATC N01AX03

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeN01AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521918605
10 VIAL in 1 TRAY (65219-186-05) / 5 mL in 1 VIAL (65219-186-01)

Annotations

UNII (FDA Substance ID)

O18YUO0I83

KETAMINE HYDROCHLORIDE

RxCUI 203184

Orange Book

A215808

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Ketamine Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "O18YUO0I83",
    "rxcui": "203184",
    "inchikey": "VCMGMSHEPQENPE-UHFFFAOYSA-N",
    "display_name": "KETAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "b96a0a23-3ca0-4a92-bd8b-1e9921931772": {
      "match": "brand_token",
      "title": "KETAMINE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]",
      "spl_version": "6",
      "published_date": "2026-04-17"
    }
  },
  "productid": "65219-186_9acdebb0-6e88-42b2-ac45-da51aaad0f3c",
  "productndc": "65219-186",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215808",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jan 13, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/ML",
        "product_no": "002",
        "approval_date": "Jan 13, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/ML",
        "product_no": "003",
        "approval_date": "Apr 18, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETAMINE HYDROCHLORIDE",
  "shortage_reason": "Ketamine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "ketamine hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215808",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ketamine hydrochloride",
  "start_marketing_date": "20230710",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N01AX03.

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