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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
- ndc111310710801100 TABLET in 1 BOTTLE (13107-108-01)
- ndc111310710805500 TABLET in 1 BOTTLE (13107-108-05)
- ndc11131071082020 TABLET in 1 BOTTLE (13107-108-20)
- ndc1113107108991000 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
Other records sharing ATC code N02AA03.
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