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United States · US · US:63323-178_d40f0ff2-4abf-4030-b4e1-2b85ad7448a0
Sterile Water
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633231787610 BAG in 1 CASE (63323-178-76) / 1000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
A209689
AP
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": "INTRAVENOUS",
"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": "63323-178_d40f0ff2-4abf-4030-b4e1-2b85ad7448a0",
"productndc": "63323-178",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "209689",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100%",
"product_no": "001",
"approval_date": "Nov 24, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "WATER",
"proprietary_name": "Sterile Water",
"active_ingred_unit": "mL/1000mL",
"application_number": "ANDA209689",
"marketing_category": "ANDA",
"nonproprietary_name": "Water",
"start_marketing_date": "20171124",
"active_numerator_strength": "1000"
}Access this data programmatically
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