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United States · US · US:70748-332_8b7144d6-fff1-4afd-a80b-332ff7ed80a1
PREDNISOLONE ACETATE
Orange BookUNIISPLATC S02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1170748332021 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE
- ndc1170748332031 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE
- ndc1170748332041 BOTTLE in 1 CARTON (70748-332-04) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
8B2807733D
PREDNISOLONE ACETATE
RxCUI 34372
Orange Book
A216935
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8B2807733D",
"rxcui": "34372",
"inchikey": "LRJOMUJRLNCICJ-JZYPGELDSA-N",
"display_name": "PREDNISOLONE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"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": "70748-332_8b7144d6-fff1-4afd-a80b-332ff7ed80a1",
"productndc": "70748-332",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "216935",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1%",
"product_no": "001",
"approval_date": "Aug 2, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PREDNISOLONE ACETATE",
"proprietary_name": "PREDNISOLONE ACETATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216935",
"marketing_category": "ANDA",
"nonproprietary_name": "prednisolone acetate",
"start_marketing_date": "20241011",
"active_numerator_strength": "10"
}Related drugs
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Access this data programmatically
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