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United States · US · US:63323-024_fe8beed4-a8db-400e-834e-b5efe2f5af1c
Mannitol
Orange BookUNIISPLATC B05CX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB05CX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633230242525 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01)
Annotations
UNII (FDA Substance ID)
3OWL53L36A
MANNITOL
RxCUI 6628
Orange Book
A080677
AP
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": "INTRAVENOUS",
"spl_meta": {
"8ad3145e-00e7-4412-b9a5-06f00f264f30": {
"match": "brand_token",
"title": "MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "23",
"published_date": "2026-04-23"
}
},
"productid": "63323-024_fe8beed4-a8db-400e-834e-b5efe2f5af1c",
"productndc": "63323-024",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "080677",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "12.5GM/50ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MANNITOL",
"proprietary_name": "Mannitol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA080677",
"marketing_category": "ANDA",
"nonproprietary_name": "MANNITOL",
"start_marketing_date": "20000319",
"active_numerator_strength": "250"
}Related drugs
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