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United States · US · US:62135-833_10594df5-e2d0-a24e-e063-6394a90afe26
Sterile Water
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11621358338430 VIAL, SINGLE-DOSE in 1 CARTON (62135-833-84) / 5 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
A211222
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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"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": "62135-833_10594df5-e2d0-a24e-e063-6394a90afe26",
"productndc": "62135-833",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "211222",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100% (5ML)",
"product_no": "001",
"approval_date": "Feb 10, 2021"
}
],
"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": "ANDA211222",
"marketing_category": "ANDA",
"nonproprietary_name": "Sterile Water",
"start_marketing_date": "20210607",
"active_numerator_strength": "1"
}Access this data programmatically
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