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United States · US · US:59651-484_6f9a9020-efd5-4f7d-90c7-11af33e93793

PREDNISONE

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5965148401
    100 TABLET in 1 BOTTLE (59651-484-01)
  • ndc11
    5965148478
    10 BLISTER PACK in 1 CARTON (59651-484-78) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5965148499
    1000 TABLET in 1 BOTTLE (59651-484-99)

Annotations

UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A215671
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": "59651-484_6f9a9020-efd5-4f7d-90c7-11af33e93793",
  "productndc": "59651-484",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215671",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "PREDNISONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215671",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREDNISONE",
  "start_marketing_date": "20211116",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A07EA03.

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