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United States · US · US:59212-702_d172c0d5-b118-4433-92bd-05214976dd8f
Orapred
Orange BookUNIISPLATC S02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeS02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159212702122 BLISTER PACK in 1 CARTON (59212-702-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-702-06)
Annotations
UNII (FDA Substance ID)
IV021NXA9J
PREDNISOLONE SODIUM PHOSPHATE
RxCUI 55062
Orange Book
N021959
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "IV021NXA9J",
"rxcui": "55062",
"inchikey": "VJZLQIPZNBPASX-OJJGEMKLSA-L",
"display_name": "PREDNISOLONE SODIUM PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1e379543-c4cf-4e72-953b-db15b7f0c2a1": {
"match": "brand_token",
"title": "ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [ADVANZ PHARMA (US) CORP.]",
"spl_version": "12",
"published_date": "2025-06-20"
}
},
"productid": "59212-702_d172c0d5-b118-4433-92bd-05214976dd8f",
"productndc": "59212-702",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "021959",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jun 1, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 15MG BASE",
"product_no": "002",
"approval_date": "Jun 1, 2006"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "003",
"approval_date": "Jun 1, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREDNISOLONE SODIUM PHOSPHATE",
"proprietary_name": "Orapred",
"active_ingred_unit": "mg/1",
"application_number": "NDA021959",
"marketing_category": "NDA",
"nonproprietary_name": "prednisolone sodium phosphate",
"start_marketing_date": "20060601",
"active_numerator_strength": "30"
}Related drugs
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- GBDilacort 2.5mg gastro-resistant tabletsAuden McKenzie (Pharma Division) Ltd
- GBDilacort 2.5mg gastro-resistant tabletsCrescent Pharma Ltd
- GBDilacort 5mg gastro-resistant tabletsTeva UK Ltd
- GBDilacort 5mg gastro-resistant tabletsCrescent Pharma Ltd
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