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United States · US · US:0591-5052_6e6cf2e7-c839-4c9f-a58a-fea5023fb432

Prednisone

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0591505201
    100 TABLET in 1 BOTTLE (0591-5052-01)
  • ndc11
    0591505210
    1000 TABLET in 1 BOTTLE (0591-5052-10)
  • ndc11
    0591505221
    1 BLISTER PACK in 1 CARTON (0591-5052-21) / 21 TABLET in 1 BLISTER PACK
  • ndc11
    0591505243
    1 BLISTER PACK in 1 CARTON (0591-5052-43) / 48 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A080356
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": "0591-5052_6e6cf2e7-c839-4c9f-a58a-fea5023fb432",
  "productndc": "0591-5052",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "080356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "Prednisone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA080356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisone",
  "start_marketing_date": "19900101",
  "active_numerator_strength": "5"
}

Related drugs

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