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United States · US · US:71335-2753_d41fab26-b03f-4bee-a72a-06829cf538d7

PredniSONE Tablets, USP, 5 mg

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133527530
    42 TABLET in 1 BOTTLE (71335-2753-0)
  • ndc11
    7133527531
    30 TABLET in 1 BOTTLE (71335-2753-1)
  • ndc11
    7133527532
    78 TABLET in 1 BOTTLE (71335-2753-2)
  • ndc11
    7133527533
    36 TABLET in 1 BOTTLE (71335-2753-3)
  • ndc11
    7133527534
    21 TABLET in 1 BOTTLE (71335-2753-4)
  • ndc11
    7133527535
    15 TABLET in 1 BOTTLE (71335-2753-5)
  • ndc11
    7133527536
    100 TABLET in 1 BOTTLE (71335-2753-6)
  • ndc11
    7133527537
    20 TABLET in 1 BOTTLE (71335-2753-7)
  • ndc11
    7133527538
    10 TABLET in 1 BOTTLE (71335-2753-8)
  • ndc11
    7133527539
    90 TABLET in 1 BOTTLE (71335-2753-9)

Annotations

UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A212629
ABABAB
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": "71335-2753_d41fab26-b03f-4bee-a72a-06829cf538d7",
  "productndc": "71335-2753",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212629",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Dec 5, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "PredniSONE Tablets, USP, 5 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212629",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PredniSONE",
  "start_marketing_date": "20250522",
  "active_numerator_strength": "5"
}

Related drugs

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