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United States · US · US:0781-6021_fe80d00e-9eba-4192-9515-f9a5ad686a53
DILUENT
Orange BookUNII
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107816021941 VIAL in 1 CARTON (0781-6021-94) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
059QF0KO0R
WATER
RxCUI 11295
Orange Book
A203649
APAPAPAP
Raw payload (JSON)
{
"unii": {
"unii": "059QF0KO0R",
"rxcui": "11295",
"inchikey": "XLYOFNOQVPJJNP-UHFFFAOYSA-N",
"display_name": "WATER",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS; SUBCUTANEOUS",
"productid": "0781-6021_fe80d00e-9eba-4192-9515-f9a5ad686a53",
"productndc": "0781-6021",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "203649",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Nov 30, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2.5MG/ML",
"product_no": "002",
"approval_date": "Nov 30, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5MG/ML",
"product_no": "003",
"approval_date": "Nov 30, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "004",
"approval_date": "Nov 30, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "WATER",
"proprietary_name": "DILUENT",
"active_ingred_unit": "mL/mL",
"application_number": "ANDA203649",
"marketing_category": "ANDA",
"nonproprietary_name": "water solution",
"start_marketing_date": "20190325",
"active_numerator_strength": "1"
}Access this data programmatically
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