PredniSONE Tablets, USP, 20 mg

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerGranulation Technology, Inc.

CountryUS (United States)

ATC codeA07EA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6356101221
100 TABLET in 1 BOTTLE (63561-0122-1)
ndc11
6356101222
1000 TABLET in 1 BOTTLE (63561-0122-2)
ndc11
6356101225
500 TABLET in 1 BOTTLE (63561-0122-5)

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": "63561-0122_3c696af0-7946-dd78-e063-6394a90a71cc",
  "productndc": "63561-0122",
  "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, 20 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212629",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PredniSONE",
  "start_marketing_date": "20250522",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A07EA03.

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