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United States · US · US:31722-121_8b32d26f-fcb6-43f3-bfd3-8769e9ca6138

hydromorphone hydrochloride

In shortageOrange BookUNIISPLATC N02AA03

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN02AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3172212101
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-121-01)

Annotations

UNII (FDA Substance ID)
L960UP2KRW
HYDROMORPHONE HYDROCHLORIDE
RxCUI 203177
Orange Book
A212133
ABABABAB
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": "ORAL",
  "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": "31722-121_8b32d26f-fcb6-43f3-bfd3-8769e9ca6138",
  "productndc": "31722-121",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212133",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12MG",
        "product_no": "002",
        "approval_date": "Sep 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "003",
        "approval_date": "Sep 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG",
        "product_no": "004",
        "approval_date": "Sep 23, 2020"
      }
    ],
    "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/1",
  "application_number": "ANDA212133",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydromorphone hydrochloride",
  "start_marketing_date": "20200924",
  "active_numerator_strength": "16"
}

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