PredniSONE

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeA07EA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051842710
100 POUCH in 1 BOX (70518-4271-0) / 1 TABLET in 1 POUCH (70518-4271-1)

Annotations

UNII (FDA Substance ID)

VB0R961HZT

PREDNISONE

RxCUI 8640

Orange Book

A080352

ABABABABABAB

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": "70518-4271_4018f32d-5c0d-392b-e063-6394a90a83eb",
  "productndc": "70518-4271",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "080352",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Apr 22, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "003",
        "approval_date": "Apr 22, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "006",
        "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": "ANDA080352",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PredniSONE",
  "start_marketing_date": "20250130",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code A07EA03.

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