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United States · US · US:0143-9339_2558c762-cdc9-4135-a83e-8d4c5c9d1afc
Sterile Water
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014393391212 BAG in 1 CASE (0143-9339-12) / 1000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
A212735
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": "0143-9339_2558c762-cdc9-4135-a83e-8d4c5c9d1afc",
"productndc": "0143-9339",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "212735",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100%",
"product_no": "001",
"approval_date": "Jan 31, 2023"
}
],
"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": "ANDA212735",
"marketing_category": "ANDA",
"nonproprietary_name": "Sterile Water",
"start_marketing_date": "20230505",
"active_numerator_strength": "1"
}Access this data programmatically
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