NDC directory

Methylprednisolone Acetate

Gland Pharma Limited · INJECTION, SUSPENSION

68083-621ANDACorticosteroid Hormone Receptor Agonists [MoA]
Product NDC
68083-621
Generic name
Methylprednisolone Acetate
Labeler name
Gland Pharma Limited
Brand name
Methylprednisolone Acetate
Finished
true
Listing expiration date
20271231
Marketing category
ANDA
Dosage form
INJECTION, SUSPENSION
SPL ID
6fb53451-fb9a-4360-9619-1cd302820782
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20261102
Product ID
68083-621_6fb53451-fb9a-4360-9619-1cd302820782
Application number
ANDA219662
Brand name base
Methylprednisolone Acetate
Active ingredients
  1. Name
    METHYLPREDNISOLONE ACETATE
    Strength
    40 mg/mL
Packaging
  1. Package NDC
    68083-621-01
    Description
    1 VIAL, MULTI-DOSE in 1 CARTON (68083-621-01) / 10 mL in 1 VIAL, MULTI-DOSE
    Marketing start date
    20261102
    Sample
    false
  2. Package NDC
    68083-621-25
    Description
    25 VIAL, MULTI-DOSE in 1 CARTON (68083-621-25) / 10 mL in 1 VIAL, MULTI-DOSE
    Marketing start date
    20261102
    Sample
    false
Route
INTRALESIONAL, INTRAMUSCULAR, INTRASYNOVIAL, SOFT TISSUE
Pharm class
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.