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United States · US · US:74157-010_463c5b39-7eb2-d396-e063-6394a90aa451

Prednisone delayed release

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerINA Pharmaceutics Inc
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7415701030
    1 BOTTLE in 1 CARTON (74157-010-30) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
VB0R961HZT
PREDNISONE
RxCUI 8640
Orange Book
A219477
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": "74157-010_463c5b39-7eb2-d396-e063-6394a90aa451",
  "productndc": "74157-010",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "219477",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Oct 1, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Oct 1, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "Prednisone delayed release",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219477",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisone",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "1"
}

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