Hydromorphone Hydrochloride

In shortageOrange BookUNIISPLATC N02AA03

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

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeN02AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
8706303801
100 TABLET in 1 BOTTLE, PLASTIC (87063-038-01)
ndc11
8706303805
5 TABLET in 1 BOTTLE, PLASTIC (87063-038-05)
ndc11
8706303807
7 TABLET in 1 BOTTLE, PLASTIC (87063-038-07)
ndc11
8706303810
10 TABLET in 1 BOTTLE, PLASTIC (87063-038-10)
ndc11
8706303814
14 TABLET in 1 BOTTLE, PLASTIC (87063-038-14)
ndc11
8706303820
20 TABLET in 1 BOTTLE, PLASTIC (87063-038-20)
ndc11
8706303830
30 TABLET in 1 BOTTLE, PLASTIC (87063-038-30)
ndc11
8706303850
500 TABLET in 1 BOTTLE, PLASTIC (87063-038-50)
ndc11
8706303860
60 TABLET in 1 BOTTLE, PLASTIC (87063-038-60)
ndc11
8706303890
90 TABLET in 1 BOTTLE, PLASTIC (87063-038-90)

Annotations

UNII (FDA Substance ID)

L960UP2KRW

HYDROMORPHONE HYDROCHLORIDE

RxCUI 203177

Orange Book

N019892

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": "87063-038_451ccd08-4749-97a1-e063-6294a90ac5ad",
  "productndc": "87063-038",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019892",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "001",
        "approval_date": "Dec 7, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Nov 9, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Nov 9, 2007"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA019892",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Hydromorphone Hydrochloride",
  "start_marketing_date": "20091123",
  "active_numerator_strength": "4"
}

Related drugs

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