PREDNISONE

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeA07EA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8706304301
100 TABLET in 1 BOTTLE (87063-043-01)
ndc11
8706304318
18 TABLET in 1 BOTTLE (87063-043-18)
ndc11
8706304320
20 TABLET in 1 BOTTLE (87063-043-20)
ndc11
8706304321
21 TABLET in 1 BOTTLE (87063-043-21)
ndc11
8706304330
30 TABLET in 1 BOTTLE (87063-043-30)
ndc11
8706304360
60 TABLET in 1 BOTTLE (87063-043-60)
ndc11
8706304378
10 BLISTER PACK in 1 CARTON (87063-043-78) / 10 TABLET in 1 BLISTER PACK
ndc11
8706304390
90 TABLET in 1 BOTTLE (87063-043-90)

Annotations

UNII (FDA Substance ID)

VB0R961HZT

PREDNISONE

RxCUI 8640

Orange Book

A215672

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": "87063-043_4a1001c0-0013-e6a5-e063-6294a90af48e",
  "productndc": "87063-043",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215672",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Mar 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Mar 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Mar 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Mar 28, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "PREDNISONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215672",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREDNISONE",
  "start_marketing_date": "20220328",
  "active_numerator_strength": "5"
}

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