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United States · US · US:0338-0003_97390588-b679-4caa-b7f3-3d2e11074d0e
Sterile Water
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11033800034414 BAG in 1 CARTON (0338-0003-44) / 1000 mL in 1 BAG
- ndc1103380003466 BAG in 1 CARTON (0338-0003-46) / 2000 mL in 1 BAG
- ndc1103380003474 BAG in 1 CARTON (0338-0003-47) / 3000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
N017866
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": "0338-0003_97390588-b679-4caa-b7f3-3d2e11074d0e",
"productndc": "0338-0003",
"dosage_form": "IRRIGANT",
"orange_book": {
"appl_no": "017866",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100%",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "WATER",
"proprietary_name": "Sterile Water",
"active_ingred_unit": "mL/100mL",
"application_number": "NDA017866",
"marketing_category": "NDA",
"nonproprietary_name": "Water",
"start_marketing_date": "19800530",
"active_numerator_strength": "100"
}Access this data programmatically
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