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United States · US · US:13107-108_1c45740c-5fb6-4cf7-81b9-0865717334e5

HYDROMORPHONE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N02AA03

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

Identification

ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeN02AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1310710801
    100 TABLET in 1 BOTTLE (13107-108-01)
  • ndc11
    1310710805
    500 TABLET in 1 BOTTLE (13107-108-05)
  • ndc11
    1310710820
    20 TABLET in 1 BOTTLE (13107-108-20)
  • ndc11
    1310710899
    1000 TABLET in 1 BOTTLE (13107-108-99)

Annotations

UNII (FDA Substance ID)
L960UP2KRW
HYDROMORPHONE HYDROCHLORIDE
RxCUI 203177
Orange Book
A205814
ABABAB
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": "13107-108_1c45740c-5fb6-4cf7-81b9-0865717334e5",
  "productndc": "13107-108",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205814",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "May 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "May 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "003",
        "approval_date": "May 13, 2016"
      }
    ],
    "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": "ANDA205814",
  "marketing_category": "ANDA",
  "nonproprietary_name": "HYDROMORPHONE HYDROCHLORIDE",
  "start_marketing_date": "20160517",
  "active_numerator_strength": "4"
}

Related drugs

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