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 · 11

ndc11
7642041300
1000 TABLET in 1 BOTTLE, PLASTIC (76420-413-00)
ndc11
7642041301
100 TABLET in 1 BOTTLE, PLASTIC (76420-413-01)
ndc11
7642041305
5 TABLET in 1 BOTTLE, PLASTIC (76420-413-05)
ndc11
7642041310
10 TABLET in 1 BOTTLE, PLASTIC (76420-413-10)
ndc11
7642041318
18 TABLET in 1 BOTTLE, PLASTIC (76420-413-18)
ndc11
7642041320
20 TABLET in 1 BOTTLE, PLASTIC (76420-413-20)
ndc11
7642041321
21 TABLET in 1 BOTTLE, PLASTIC (76420-413-21)
ndc11
7642041330
30 TABLET in 1 BOTTLE, PLASTIC (76420-413-30)
ndc11
7642041350
500 TABLET in 1 BOTTLE, PLASTIC (76420-413-50)
ndc11
7642041360
60 TABLET in 1 BOTTLE, PLASTIC (76420-413-60)
ndc11
7642041390
90 TABLET in 1 BOTTLE, PLASTIC (76420-413-90)

Annotations

UNII (FDA Substance ID)

VB0R961HZT

PREDNISONE

RxCUI 8640

Orange Book

A208412

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": "76420-413_4c2b2c5f-3f84-9799-e063-6294a90a37cb",
  "productndc": "76420-413",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208412",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Feb 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jan 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "004",
        "approval_date": "Nov 20, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Nov 20, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISONE",
  "proprietary_name": "prednisone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208412",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREDNISONE",
  "start_marketing_date": "20210901",
  "active_numerator_strength": "20"
}

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