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United States · US · US:43598-887_a9e0d98c-c1bf-62b0-67b3-3b8f8313b408

Prednisone delayed release

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerDr. Reddys Laboratories Inc.
CountryUS (United States)
ATC codeA07EA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359888701
    1 BOTTLE in 1 CARTON (43598-887-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    4359888730
    1 BOTTLE in 1 CARTON (43598-887-30) / 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": "43598-887_a9e0d98c-c1bf-62b0-67b3-3b8f8313b408",
  "productndc": "43598-887",
  "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": "2"
}

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