prednisone

Orange BookUNIISPLATC A07EA03

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

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
7133521340
42 TABLET in 1 BOTTLE (71335-2134-0)
ndc11
7133521341
30 TABLET in 1 BOTTLE (71335-2134-1)
ndc11
7133521342
78 TABLET in 1 BOTTLE (71335-2134-2)
ndc11
7133521343
36 TABLET in 1 BOTTLE (71335-2134-3)
ndc11
7133521344
21 TABLET in 1 BOTTLE (71335-2134-4)
ndc11
7133521345
15 TABLET in 1 BOTTLE (71335-2134-5)
ndc11
7133521346
100 TABLET in 1 BOTTLE (71335-2134-6)
ndc11
7133521347
20 TABLET in 1 BOTTLE (71335-2134-7)
ndc11
7133521348
10 TABLET in 1 BOTTLE (71335-2134-8)
ndc11
7133521349
90 TABLET in 1 BOTTLE (71335-2134-9)

Annotations

UNII (FDA Substance ID)

VB0R961HZT

PREDNISONE

RxCUI 8640

Orange Book

A208412

ABABABABAB

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": "71335-2134_5a830fcf-56f9-4328-8a87-82ddc72e8763",
  "productndc": "71335-2134",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208412",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Feb 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jan 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "004",
        "approval_date": "Nov 20, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Nov 20, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "prednisone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208412",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREDNISONE",
  "start_marketing_date": "20210901",
  "active_numerator_strength": "5"
}

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