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United States · US · US:60722-5011_da9dfcf4-1631-4923-9536-72c27fc0b307
PREDNISOLONE
Orange BookUNIISPLATC S02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZhejiang Xianju Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeS02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116072250110100 TABLET in 1 BOTTLE (60722-5011-0)
- ndc1160722501111000 TABLET in 1 BOTTLE (60722-5011-1)
Annotations
UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A218083
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9PHQ9Y1OLM",
"rxcui": "8638",
"inchikey": "OIGNJSKKLXVSLS-VWUMJDOOSA-N",
"display_name": "PREDNISOLONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"02fc6f0b-d053-49e1-82de-f272dd05d529": {
"match": "brand_token",
"title": "PREDNISOLONE ACETATE SUSPENSION/ DROPS [SPORTPHARM LLC]",
"spl_version": "2",
"published_date": "2026-04-27"
}
},
"productid": "60722-5011_da9dfcf4-1631-4923-9536-72c27fc0b307",
"productndc": "60722-5011",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218083",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 2, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREDNISOLONE",
"proprietary_name": "PREDNISOLONE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218083",
"marketing_category": "ANDA",
"nonproprietary_name": "PREDNISOLONE",
"start_marketing_date": "20240901",
"active_numerator_strength": "5"
}Related drugs
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