METHYLPREDNISOLONE ACETATE

Product NDC
0781-3522
11-digit product format
007813522
Labeler code
0781
Product ID
0781-3522_ab8910e5-0b8c-4057-a95d-4519ce85835b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPREDNISOLONE ACETATE
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
Sandoz Inc.
Application
ANDA214870
Marketing category
ANDA
Marketing start
2024-03-14
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
43502P7F0PMETHYLPREDNISOLONE ACETATE53-36-1METHYLPREDNISOLONE ACETATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0781-3522-70007813522701 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-70) / 10 mL in 1 VIAL, MULTI-DOSE2024-03-14NoNoHistorical
0781-3522-75007813522751 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-75) / 5 mL in 1 VIAL, MULTI-DOSE2024-03-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Physicians EZ Use M-predAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-10-30HUMAN PRESCRIPTION DRUG LABEL13
Methylprednisolone Acetate Injectable Suspension, USPSandoz Inc. | Lisapharma SPA2024-03-01Human Prescription Drug Label7