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United States · US · US:62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05
Prednisolone
Orange BookUNIISPLATC S02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeS02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11621354373030 TABLET in 1 BOTTLE (62135-437-30)
Annotations
UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A080531
BX
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": "62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05",
"productndc": "62135-437",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "080531",
"products": [
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "5MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREDNISOLONE",
"proprietary_name": "Prednisolone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA080531",
"marketing_category": "ANDA",
"nonproprietary_name": "Prednisolone",
"start_marketing_date": "19740531",
"active_numerator_strength": "5"
}Related drugs
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