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United States · US · US:60219-1708_8a3eba28-c6c2-4937-a75f-dc4b737002cd

prednisone

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6021917081
    100 TABLET in 1 BOTTLE, PLASTIC (60219-1708-1)
  • ndc11
    6021917085
    500 TABLET in 1 BOTTLE, PLASTIC (60219-1708-5)

Annotations

UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A213386
ABAB
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": "60219-1708_8a3eba28-c6c2-4937-a75f-dc4b737002cd",
  "productndc": "60219-1708",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213386",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jun 24, 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": "ANDA213386",
  "marketing_category": "ANDA",
  "nonproprietary_name": "prednisone",
  "start_marketing_date": "20200624",
  "active_numerator_strength": "20"
}

Related drugs

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