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United States · US · US:0338-0013_d23ead89-2b87-4348-a785-c10da979513d
Sterile Water
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Company
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1103380013062000 mL in 1 BAG (0338-0013-06)
- ndc1103380013083000 mL in 1 BAG (0338-0013-08)
- ndc1103380013295000 mL in 1 BAG (0338-0013-29)
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
N018632
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": "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": "0338-0013_d23ead89-2b87-4348-a785-c10da979513d",
"productndc": "0338-0013",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "018632",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "100%",
"product_no": "001",
"approval_date": "Jun 30, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "100%",
"product_no": "002",
"approval_date": "Apr 19, 1988"
}
],
"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": "NDA018632",
"marketing_category": "NDA",
"nonproprietary_name": "Water",
"start_marketing_date": "19820630",
"active_numerator_strength": "100"
}Access this data programmatically
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