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United States · US · US:0641-6151_4c244852-0374-445f-8419-72e8ec359faa
Hydromorphone Hydrochloride
In shortageOrange BookUNIISPLATC N02AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN02AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064161512525 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01)
Annotations
UNII (FDA Substance ID)
L960UP2KRW
HYDROMORPHONE HYDROCHLORIDE
RxCUI 203177
Orange Book
A202159
AP
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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"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": "0641-6151_4c244852-0374-445f-8419-72e8ec359faa",
"productndc": "0641-6151",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "202159",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Apr 27, 2018"
}
],
"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/mL",
"application_number": "ANDA202159",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydromorphone Hydrochloride",
"start_marketing_date": "20180701",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code N02AA03.
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