Back to search
🇺🇸

United States · US · US:0603-4593_6b210f06-32c0-450a-ad2b-2d0827b06f7a

MethylPREDNISolone

In shortageOrange BookUNIISPLATC H02BX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeH02BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0603459315
    1 DOSE PACK in 1 CARTON (0603-4593-15) / 21 TABLET in 1 DOSE PACK
  • ndc11
    0603459321
    100 TABLET in 1 BOTTLE, PLASTIC (0603-4593-21)

Annotations

UNII (FDA Substance ID)
X4W7ZR7023
METHYLPREDNISOLONE
RxCUI 6902
Orange Book
A040183
AB
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": "0603-4593_6b210f06-32c0-450a-ad2b-2d0827b06f7a",
  "productndc": "0603-4593",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 22, 1998"
      }
    ],
    "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": "ANDA040183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methylprednisolone",
  "start_marketing_date": "19981222",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code H02BX01.

Access this data programmatically

Query MethylPREDNISolone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.