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 · 17

ndc11
6318730005
5 TABLET in 1 BOTTLE (63187-300-05)
ndc11
6318730006
6 TABLET in 1 BOTTLE (63187-300-06)
ndc11
6318730008
8 TABLET in 1 BOTTLE (63187-300-08)
ndc11
6318730009
9 TABLET in 1 BOTTLE (63187-300-09)
ndc11
6318730010
10 TABLET in 1 BOTTLE (63187-300-10)
ndc11
6318730012
12 TABLET in 1 BOTTLE (63187-300-12)
ndc11
6318730015
15 TABLET in 1 BOTTLE (63187-300-15)
ndc11
6318730018
18 TABLET in 1 BOTTLE (63187-300-18)
ndc11
6318730020
20 TABLET in 1 BOTTLE (63187-300-20)
ndc11
6318730021
21 TABLET in 1 BOTTLE (63187-300-21)
ndc11
6318730024
24 TABLET in 1 BOTTLE (63187-300-24)
ndc11
6318730027
27 TABLET in 1 BOTTLE (63187-300-27)
ndc11
6318730028
28 TABLET in 1 BOTTLE (63187-300-28)
ndc11
6318730030
30 TABLET in 1 BOTTLE (63187-300-30)
ndc11
6318730036
36 TABLET in 1 BOTTLE (63187-300-36)
ndc11
6318730040
40 TABLET in 1 BOTTLE (63187-300-40)
ndc11
6318730042
42 TABLET in 1 BOTTLE (63187-300-42)

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": "63187-300_7a33b3c9-ca90-4d15-aacf-5a8f91b804a4",
  "productndc": "63187-300",
  "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": "10"
}

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