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United States · US · US:65145-183_84dbb392-4535-4cbc-af60-75abb494f26e
Desmopressin Acetate
In shortageOrange BookUNIISPLATC H01BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeH01BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11651451831010 VIAL, SINGLE-DOSE in 1 CARTON (65145-183-10) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-183-01)
Annotations
UNII (FDA Substance ID)
XB13HYU18U
DESMOPRESSIN ACETATE
RxCUI 42634
Orange Book
A219981
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Desmopressin Acetate Spray
Raw payload (JSON)
{
"unii": {
"unii": "XB13HYU18U",
"rxcui": "42634",
"inchikey": "YNKFCNRZZPFMEX-XHPDKPNGSA-N",
"display_name": "DESMOPRESSIN ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f140926e-3201-4b8e-8207-14c560ddb55e": {
"match": "brand_token",
"title": "DESMOPRESSIN ACETATE TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-04-27"
}
},
"productid": "65145-183_84dbb392-4535-4cbc-af60-75abb494f26e",
"productndc": "65145-183",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "219981",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.004MG/ML",
"product_no": "001",
"approval_date": "Feb 27, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DESMOPRESSIN ACETATE",
"shortage_reason": "Desmopressin Acetate Spray",
"shortage_status": "current",
"proprietary_name": "Desmopressin Acetate",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA219981",
"marketing_category": "ANDA",
"nonproprietary_name": "Desmopressin Acetate",
"start_marketing_date": "20260316",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code H01BA02.
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