Methylprednisolone

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6318716021
21 TABLET in 1 BLISTER PACK (63187-160-21)

Annotations

UNII (FDA Substance ID)

X4W7ZR7023

METHYLPREDNISOLONE

RxCUI 6902

Orange Book

A040189

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylprednisolone Acetate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "X4W7ZR7023",
    "rxcui": "6902",
    "inchikey": "VHRSUDSXCMQTMA-PJHHCJLFSA-N",
    "display_name": "METHYLPREDNISOLONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7092df48-4904-4047-9916-e585417a216f": {
      "match": "brand_token",
      "title": "METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "63187-160_d1e24bea-ccf4-453d-b5b6-7a44e78c7069",
  "productndc": "63187-160",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040189",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Oct 31, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Oct 31, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "003",
        "approval_date": "Jul 20, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG",
        "product_no": "004",
        "approval_date": "Jul 20, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPREDNISOLONE",
  "shortage_reason": "Methylprednisolone Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Methylprednisolone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040189",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylprednisolone",
  "start_marketing_date": "19971031",
  "active_numerator_strength": "4"
}

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