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United States · US · US:0527-5406_5122ba73-5783-49f0-9b9c-a03d59d8899c
PrednisoLONE
Orange BookUNIISPLATC S02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeS02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110527540668240 mL in 1 BOTTLE (0527-5406-68)
- ndc110527540670480 mL in 1 BOTTLE (0527-5406-70)
Annotations
UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A040775
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": "0527-5406_5122ba73-5783-49f0-9b9c-a03d59d8899c",
"productndc": "0527-5406",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "040775",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "15MG/5ML",
"product_no": "001",
"approval_date": "Sep 21, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREDNISOLONE",
"proprietary_name": "PrednisoLONE",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA040775",
"marketing_category": "ANDA",
"nonproprietary_name": "Prednisolone",
"start_marketing_date": "20070921",
"active_numerator_strength": "15"
}Related drugs
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