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United States · US · US:0990-7981_dda87a72-d2a8-41f8-8d73-52931a149dc0
Sorbitol-Mannitol
Orange BookUNIISPLATC A06AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerICU Medical Inc.
CountryUS (United States)
ATC codeA06AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1109907981084 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
3OWL53L36A
MANNITOL
RxCUI 6628
Orange Book
N018316
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3OWL53L36A",
"rxcui": "6628",
"inchikey": "FBPFZTCFMRRESA-KVTDHHQDSA-N",
"display_name": "MANNITOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "URETHRAL",
"spl_meta": {
"5b44e248-4b7b-4777-954a-921c7b309944": {
"match": "brand_token",
"title": "SORBITOL-MANNITOL (SORBITOL AND MANNITOL) IRRIGANT [ICU MEDICAL INC.]",
"spl_version": "7",
"published_date": "2025-11-17"
}
},
"productid": "0990-7981_dda87a72-d2a8-41f8-8d73-52931a149dc0",
"productndc": "0990-7981",
"dosage_form": "IRRIGANT",
"orange_book": {
"appl_no": "018316",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "540MG/100ML;2.7GM/100ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MANNITOL; SORBITOL",
"proprietary_name": "Sorbitol-Mannitol",
"active_ingred_unit": "g/100mL; g/100mL",
"application_number": "NDA018316",
"marketing_category": "NDA",
"nonproprietary_name": "SORBITOL and MANNITOL",
"start_marketing_date": "20191001",
"active_numerator_strength": ".54; 2.7"
}Related drugs
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