PredniSONE Tablets, USP, 5 mg

Orange BookUNIISPLATC A07EA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA07EA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7278947401
100 TABLET in 1 BOTTLE, PLASTIC (72789-474-01)
ndc11
7278947404
4 TABLET in 1 BOTTLE, PLASTIC (72789-474-04)
ndc11
7278947421
21 TABLET in 1 BOTTLE, PLASTIC (72789-474-21)
ndc11
7278947495
1000 TABLET in 1 BOTTLE, PLASTIC (72789-474-95)

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": "72789-474_4ddfaff7-3273-e76e-e063-6294a90a01c9",
  "productndc": "72789-474",
  "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

Other records sharing ATC code A07EA03.

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