Prednisone

Orange BookUNIISPLATC A07EA03

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA07EA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 16

ndc11
6318780705
5 TABLET in 1 BOTTLE (63187-807-05)
ndc11
6318780706
6 TABLET in 1 BOTTLE (63187-807-06)
ndc11
6318780707
7 TABLET in 1 BOTTLE (63187-807-07)
ndc11
6318780708
8 TABLET in 1 BOTTLE (63187-807-08)
ndc11
6318780709
9 TABLET in 1 BOTTLE (63187-807-09)
ndc11
6318780710
10 TABLET in 1 BOTTLE (63187-807-10)
ndc11
6318780712
12 TABLET in 1 BOTTLE (63187-807-12)
ndc11
6318780714
14 TABLET in 1 BOTTLE (63187-807-14)
ndc11
6318780715
15 TABLET in 1 BOTTLE (63187-807-15)
ndc11
6318780718
18 TABLET in 1 BOTTLE (63187-807-18)
ndc11
6318780720
20 TABLET in 1 BOTTLE (63187-807-20)
ndc11
6318780721
21 TABLET in 1 BOTTLE (63187-807-21)
ndc11
6318780724
24 TABLET in 1 BOTTLE (63187-807-24)
ndc11
6318780730
30 TABLET in 1 BOTTLE (63187-807-30)
ndc11
6318780740
40 TABLET in 1 BOTTLE (63187-807-40)
ndc11
6318780742
42 TABLET in 1 BOTTLE (63187-807-42)

Annotations

UNII (FDA Substance ID)

VB0R961HZT

PREDNISONE

RxCUI 8640

Orange Book

A040362

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": "63187-807_69508b79-c086-493a-a46f-b9ab7c60a519",
  "productndc": "63187-807",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040362",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Aug 29, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Jun 29, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "004",
        "approval_date": "Apr 17, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "005",
        "approval_date": "Apr 17, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "Prednisone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040362",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisone",
  "start_marketing_date": "20010829",
  "active_numerator_strength": "20"
}

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