Methylprednisolone Acetate Injection, USP, 80mg/mL, 1 mL Single-Dose Vial – Case (25 Vials)

Product Specifications

Specification	Details
Manufacturer / Brand	Amneal Biosciences, LLC
Manufacturer # (Single)	70121157401 (1 mL Vial)
Manufacturer # (Case)	70121157405 (25 x 1 mL Vials)
NDC Number	70121-1574-01 (Single) / 70121-1574-05 (Case)
Active Ingredient	Methylprednisolone Acetate
Strength	80 mg / mL
Volume per Unit	1 mL
Container Type	Single-Dose Vial (SDV)
Storage	20°C to 25°C (68°F to 77°F); Do not freeze

Key Features

• High Concentration: The 80 mg/mL strength allows for a smaller volume of injection compared to the 40 mg version, increasing patient comfort in localized joint therapy.

• Extended Release Profile: Formulated as an acetate ester to provide slow absorption and long-lasting therapeutic action (up to several weeks depending on site).

• Single-Dose Integrity: Each 1 mL vial is designed for single-patient use to maintain aseptic standards and prevent cross-contamination.

• Superior Anti-Inflammatory Power: Effectively reduces pain, swelling, and redness associated with severe inflammatory flares.

• Sterile Aqueous Suspension: Engineered for smooth delivery through fine-gauge needles for precise intra-articular placement.

Clinical Applications

• Rheumatology: Intra-articular injection for osteoarthritis and rheumatoid arthritis flare-ups.

• Dermatology: Intralesional treatment for severe inflammatory skin conditions.

• Systemic Therapy: Deep intramuscular injection for severe allergic states, asthma, or ulcerative colitis.

⚠️ Usage Note: INTRAMUSCULAR OR INTRA-ARTICULAR USE ONLY. Not for Intravenous (IV) use.

⚠️ Safety Alert: Shake well before use to ensure a uniform suspension. Discard any unused portion of the single-dose vial.

⚠️ Caution: Use with extreme care in patients with suspected infection at the injection site. Corticosteroids may mask signs of infection.