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United States · US · US:62135-250_19febba3-956f-d1a9-e063-6394a90afda5
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 · 3
- ndc1162135250242 TRAY in 1 BOX (62135-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45)
- ndc116213525037240 mL in 1 BOTTLE (62135-250-37)
- ndc116213525047480 mL in 1 BOTTLE (62135-250-47)
Annotations
UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A040323
AA
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": "62135-250_19febba3-956f-d1a9-e063-6394a90afda5",
"productndc": "62135-250",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "040323",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "15MG/5ML",
"product_no": "001",
"approval_date": "May 13, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREDNISOLONE",
"proprietary_name": "Prednisolone",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA040323",
"marketing_category": "ANDA",
"nonproprietary_name": "Prednisolone oral",
"start_marketing_date": "20221120",
"active_numerator_strength": "15"
}Related drugs
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Access this data programmatically
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