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United States · US · US:61919-365_4d3fa8d2-31a1-759a-e063-6294a90a0267

PREDNISONE

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerDIRECT RX
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6191936521
    21 TABLET in 1 DOSE PACK (61919-365-21)

Annotations

UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A040584
AB
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": "61919-365_4d3fa8d2-31a1-759a-e063-6294a90a0267",
  "productndc": "61919-365",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040584",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "PREDNISONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040584",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREDNISONE",
  "start_marketing_date": "20140101",
  "active_numerator_strength": "5"
}

Related drugs

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