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United States · US · US:42858-234_3348b431-907c-4f1d-8a18-e4be2a04df23
Dilaudid
In shortageOrange BookUNIISPLATC N02AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRhodes Pharmaceuticals LLC
CountryUS (United States)
ATC codeN02AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114285823401100 TABLET in 1 BOTTLE, PLASTIC (42858-234-01)
- ndc114285823450500 TABLET in 1 BOTTLE, PLASTIC (42858-234-50)
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": {
"d6b40e39-a57e-402c-b4f6-7041e832f837": {
"match": "brand_token",
"title": "DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET DILAUDID (HYDROMORPHONE HYDROCHLORIDE) SOLUTION [RHODES PHARMACEUTICALS LLC]",
"spl_version": "12",
"published_date": "2026-05-20"
}
},
"productid": "42858-234_3348b431-907c-4f1d-8a18-e4be2a04df23",
"productndc": "42858-234",
"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": "Dilaudid",
"active_ingred_unit": "mg/1",
"application_number": "NDA019892",
"marketing_category": "NDA",
"nonproprietary_name": "hydromorphone hydrochloride",
"start_marketing_date": "20170515",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code N02AA03.
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