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United States · US · US:55154-0127_ae46b624-76f6-4866-8e6f-a0f2cfd63c61
Sterile Water
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155154012755 VIAL, PLASTIC in 1 BAG (55154-0127-5) / 10 mL in 1 VIAL, PLASTIC
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
N018801
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "059QF0KO0R",
"rxcui": "11295",
"inchikey": "XLYOFNOQVPJJNP-UHFFFAOYSA-N",
"display_name": "WATER",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"spl_meta": {
"39df5fc7-f66e-1605-e063-6394a90a0054": {
"match": "brand_token",
"title": "STERILE ALCOHOL PAD PATCH [KINGSTAR MEDICAL (XIANNING) CO., LTD.]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "55154-0127_ae46b624-76f6-4866-8e6f-a0f2cfd63c61",
"productndc": "55154-0127",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "018801",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Oct 27, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "100% (10ML)",
"product_no": "002",
"approval_date": "Oct 27, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "100% (20ML)",
"product_no": "003",
"approval_date": "Oct 27, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100% (50ML)",
"product_no": "004",
"approval_date": "Oct 27, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100% (100ML)",
"product_no": "005",
"approval_date": "Oct 27, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "006",
"approval_date": "May 2, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "WATER",
"proprietary_name": "Sterile Water",
"active_ingred_unit": "mL/mL",
"application_number": "NDA018801",
"marketing_category": "NDA",
"nonproprietary_name": "WATER",
"start_marketing_date": "20110915",
"active_numerator_strength": "1"
}Access this data programmatically
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