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United States · US · US:62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05

Prednisolone

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeS02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213543730
    30 TABLET in 1 BOTTLE (62135-437-30)

Annotations

UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A080531
BX
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": "62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05",
  "productndc": "62135-437",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "080531",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE",
  "proprietary_name": "Prednisolone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA080531",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisolone",
  "start_marketing_date": "19740531",
  "active_numerator_strength": "5"
}

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