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United States · US · US:0054-3721_523ad364-8d95-4679-9290-446d61f36eb5
PredniSONE Intensol
Orange BookUNIISPLATC A07EA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA07EA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11005437214430 mL in 1 BOTTLE, GLASS (0054-3721-44)
Annotations
UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A088810
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VB0R961HZT",
"rxcui": "8640",
"inchikey": "XOFYZVNMUHMLCC-ZPOLXVRWSA-N",
"display_name": "PREDNISONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ecc48869-3812-4440-a398-749b28062059": {
"match": "brand_token",
"title": "PREDNISONE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "105",
"published_date": "2026-06-01"
}
},
"productid": "0054-3721_523ad364-8d95-4679-9290-446d61f36eb5",
"productndc": "0054-3721",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "088810",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG/ML",
"product_no": "001",
"approval_date": "Feb 20, 1985"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREDNISONE",
"proprietary_name": "PredniSONE Intensol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA088810",
"marketing_category": "ANDA",
"nonproprietary_name": "PredniSONE Intensol",
"start_marketing_date": "19850220",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A07EA03.
- 🇮🇹CISON*10 cpr 25 mgGENETIC SpA
- 🇮🇹CISON*20 cpr 20 mgGENETIC SpA
- 🇮🇹CISON*20 cpr 25 mgGENETIC SpA
- 🇮🇹CISON*20 cpr 5 mgGENETIC SpA
- 🇫🇷CORTANCYL 1 mg, compriméCHEPLAPHARM ARZNEIMITTEL (ALLEMAGNE)
- 🇫🇷CORTANCYL 20 mg, comprimé sécableCHEPLAPHARM ARZNEIMITTEL (ALLEMAGNE)
- 🇫🇷CORTANCYL 5 mg, comprimé sécableCHEPLAPHARM ARZNEIMITTEL (ALLEMAGNE)
- 🇮🇹CORTIREX*20 cpr 20 mgFARTO Srl
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