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United States · US · US:63323-265_dc369096-3042-4942-9aeb-bbdf98f35bb8
Methylprednisolone Sodium Succinate
In shortageOrange BookUNIISPLATC H02BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeH02BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323265301 VIAL, MULTI-DOSE in 1 CARTON (63323-265-30) / 16 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
LEC9GKY20K
METHYLPREDNISOLONE SODIUM SUCCINATE
RxCUI 203189
Orange Book
A040612
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methylprednisolone Acetate Injection
Raw payload (JSON)
{
"unii": {
"unii": "LEC9GKY20K",
"rxcui": "203189",
"inchikey": "FQISKWAFAHGMGT-SGJOWKDISA-M",
"display_name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"7092df48-4904-4047-9916-e585417a216f": {
"match": "brand_token",
"title": "METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]",
"spl_version": "3",
"published_date": "2026-05-25"
}
},
"productid": "63323-265_dc369096-3042-4942-9aeb-bbdf98f35bb8",
"productndc": "63323-265",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "040612",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "Aug 12, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"shortage_reason": "Methylprednisolone Acetate Injection",
"shortage_status": "current",
"proprietary_name": "Methylprednisolone Sodium Succinate",
"active_ingred_unit": "g/16mL",
"application_number": "ANDA040612",
"marketing_category": "ANDA",
"nonproprietary_name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"start_marketing_date": "20041130",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code H02BX01.
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