methylprednisolone acetate

Generic: methylprednisolone acetate

Labeler: sandoz inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone acetate
Generic Name methylprednisolone acetate
Labeler sandoz inc.
Dosage Form INJECTION, SUSPENSION
Routes
INTRALESIONAL INTRAMUSCULAR INTRASYNOVIAL SOFT TISSUE
Active Ingredients

methylprednisolone acetate 40 mg/mL

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 0781-3522
Product ID 0781-3522_ab8910e5-0b8c-4057-a95d-4519ce85835b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214870
Listing Expiration 2026-12-31
Marketing Start 2024-03-14

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813522
Hyphenated Format 0781-3522

Supplemental Identifiers

RxCUI
1358610 1358617
UNII
43502P7F0P

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methylprednisolone acetate (source: ndc)
Generic Name methylprednisolone acetate (source: ndc)
Application Number ANDA214870 (source: ndc)
Routes
INTRALESIONAL INTRAMUSCULAR INTRASYNOVIAL SOFT TISSUE
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-70) / 10 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-75) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

0781-3522-70 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-70) / 10 mL in 1 VIAL, MULTI-DOSE 0781-3522-75 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-75) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

methylprednisolone acetate (40 mg/mL)

Linked Drug Pages (1)

METHYLPREDNISOLONE ACETATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRALESIONAL", "INTRAMUSCULAR", "INTRASYNOVIAL", "SOFT TISSUE"], "spl_id": "ab8910e5-0b8c-4057-a95d-4519ce85835b", "openfda": {"unii": ["43502P7F0P"], "rxcui": ["1358610", "1358617"], "spl_set_id": ["a363f0cd-9c8e-4622-9271-171706846b96"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-70)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0781-3522-70", "marketing_start_date": "20240314"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-75)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0781-3522-75", "marketing_start_date": "20240314"}], "brand_name": "METHYLPREDNISOLONE ACETATE", "product_id": "0781-3522_ab8910e5-0b8c-4057-a95d-4519ce85835b", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0781-3522", "generic_name": "METHYLPREDNISOLONE ACETATE", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPREDNISOLONE ACETATE", "active_ingredients": [{"name": "METHYLPREDNISOLONE ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA214870", "marketing_category": "ANDA", "marketing_start_date": "20240314", "listing_expiration_date": "20261231"}