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United States · US · US:70518-3540_4f586bb6-52ba-eda4-e063-6394a90a446b

prednisone

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7051835400
    30 TABLET in 1 BLISTER PACK (70518-3540-0)
  • ndc11
    7051835402
    10 TABLET in 1 BLISTER PACK (70518-3540-2)
  • ndc11
    7051835403
    30 TABLET in 1 BLISTER PACK (70518-3540-3)

Annotations

UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A213386
ABAB
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": "70518-3540_4f586bb6-52ba-eda4-e063-6394a90a446b",
  "productndc": "70518-3540",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213386",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jun 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "prednisone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213386",
  "marketing_category": "ANDA",
  "nonproprietary_name": "prednisone",
  "start_marketing_date": "20220926",
  "active_numerator_strength": "20"
}

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