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United States · US · US:59651-491_c535b93f-b31f-411f-848c-b5e6782f321f

PREDNISOLONE

Orange BookUNIISPLATC S02BA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeS02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5965149101
    100 TABLET in 1 BOTTLE (59651-491-01)
  • ndc11
    5965149150
    50 TABLET in 1 BOTTLE (59651-491-50)

Annotations

UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A215673
AB
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": "59651-491_c535b93f-b31f-411f-848c-b5e6782f321f",
  "productndc": "59651-491",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215673",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE",
  "proprietary_name": "PREDNISOLONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215673",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREDNISOLONE",
  "start_marketing_date": "20230317",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code S02BA03.

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