Hydromorphone Hydrochloride

In shortageOrange BookUNIISPLATC N02AA03

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN02AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641625910
10 SYRINGE in 1 CARTON (0641-6259-10) / 1 mL in 1 SYRINGE (0641-6259-01)

Annotations

UNII (FDA Substance ID)

L960UP2KRW

HYDROMORPHONE HYDROCHLORIDE

RxCUI 203177

Orange Book

A216899

APAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Hydromorphone Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "L960UP2KRW",
    "rxcui": "203177",
    "inchikey": "XHILEZUETWRSHC-NRGUFEMZSA-N",
    "display_name": "HYDROMORPHONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "37565441-0d95-4743-a695-d7b3326f58a1": {
      "match": "brand_token",
      "title": "HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "20",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0641-6259_08fdd324-f2ce-4a29-a6d1-fc88aa10b7ac",
  "productndc": "0641-6259",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216899",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.2MG/ML",
        "product_no": "001",
        "approval_date": "Feb 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.5MG/0.5ML",
        "product_no": "002",
        "approval_date": "Feb 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "003",
        "approval_date": "Feb 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "004",
        "approval_date": "Feb 9, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROMORPHONE HYDROCHLORIDE",
  "shortage_reason": "Hydromorphone Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Hydromorphone Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216899",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydromorphone Hydrochloride",
  "start_marketing_date": "20240426",
  "active_numerator_strength": ".2"
}

Related drugs

Other records sharing ATC code N02AA03.

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