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United States · US · US:25021-820_13e1ca54-4fc4-4e93-a52d-c9320865e3cb
methylprednisolone acetate
In shortageOrange BookUNIISPLATC H02BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeH02BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1125021820051 VIAL in 1 CARTON (25021-820-05) / 5 mL in 1 VIAL
- ndc1125021820101 VIAL in 1 CARTON (25021-820-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
43502P7F0P
METHYLPREDNISOLONE ACETATE
RxCUI 155323
Orange Book
A201835
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methylprednisolone Acetate Injection
Raw payload (JSON)
{
"unii": {
"unii": "43502P7F0P",
"rxcui": "155323",
"inchikey": "PLBHSZGDDKCEHR-LFYFAGGJSA-N",
"display_name": "METHYLPREDNISOLONE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE",
"spl_meta": {
"7092df48-4904-4047-9916-e585417a216f": {
"match": "brand_token",
"title": "METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]",
"spl_version": "3",
"published_date": "2026-05-25"
}
},
"productid": "25021-820_13e1ca54-4fc4-4e93-a52d-c9320865e3cb",
"productndc": "25021-820",
"dosage_form": "INJECTION, SUSPENSION",
"orange_book": {
"appl_no": "201835",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG/ML",
"product_no": "001",
"approval_date": "Jun 27, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "40MG/ML",
"product_no": "002",
"approval_date": "Jun 27, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "80MG/ML",
"product_no": "003",
"approval_date": "Jun 27, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLPREDNISOLONE ACETATE",
"shortage_reason": "Methylprednisolone Acetate Injection",
"shortage_status": "current",
"proprietary_name": "methylprednisolone acetate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA201835",
"marketing_category": "ANDA",
"nonproprietary_name": "methylprednisolone acetate",
"start_marketing_date": "20211115",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code H02BX01.
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