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United States · US · US:65219-499_7cd9f528-a5da-4541-bb2a-28f3669a6b42
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
- ndc1165219499304 BAG in 1 CASE (65219-499-30) / 3000 mL in 1 BAG (65219-499-03)
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
A216123
AT
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": "IRRIGATION",
"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": "65219-499_7cd9f528-a5da-4541-bb2a-28f3669a6b42",
"productndc": "65219-499",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216123",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100%",
"product_no": "001",
"approval_date": "Aug 12, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "WATER",
"proprietary_name": "Sterile Water",
"active_ingred_unit": "mL/mL",
"application_number": "ANDA216123",
"marketing_category": "ANDA",
"nonproprietary_name": "Water",
"start_marketing_date": "20250303",
"active_numerator_strength": "1"
}Access this data programmatically
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