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United States · US · US:51655-972_4960ab74-45e4-6df7-e063-6394a90ac2d9

prednisone

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    5165597220
    20 TABLET in 1 BOTTLE, PLASTIC (51655-972-20)
  • ndc11
    5165597221
    21 TABLET in 1 BOTTLE, PLASTIC (51655-972-21)
  • ndc11
    5165597227
    12 TABLET in 1 BOTTLE, PLASTIC (51655-972-27)
  • ndc11
    5165597249
    42 TABLET in 1 BOTTLE, PLASTIC (51655-972-49)
  • ndc11
    5165597251
    40 TABLET in 1 BOTTLE, PLASTIC (51655-972-51)
  • ndc11
    5165597252
    30 TABLET in 1 BOTTLE, PLASTIC (51655-972-52)
  • ndc11
    5165597253
    10 TABLET in 1 BOTTLE, PLASTIC (51655-972-53)
  • ndc11
    5165597254
    15 TABLET in 1 BOTTLE, PLASTIC (51655-972-54)

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": "51655-972_4960ab74-45e4-6df7-e063-6394a90ac2d9",
  "productndc": "51655-972",
  "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": "20220922",
  "active_numerator_strength": "10"
}

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