methylprednisolone acetate

Generic: methylprednisolone acetate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone acetate
Generic Name methylprednisolone acetate
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, SUSPENSION
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRASYNOVIAL SOFT TISSUE
Active Ingredients

methylprednisolone acetate 40 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1609
Product ID 70121-1609_924543a3-d04f-4c44-a2ee-008301b1f620
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216502
Listing Expiration 2027-12-31
Marketing Start 2023-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701211609
Hyphenated Format 70121-1609

Supplemental Identifiers

RxCUI
1358610 1358617
UPC
0370121161059
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 ANDA216502 (source: ndc)
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRASYNOVIAL SOFT TISSUE
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-1) / 10 mL in 1 VIAL, MULTI-DOSE
  • 25 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-5) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

70121-1609-1 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-1) / 10 mL in 1 VIAL, MULTI-DOSE 70121-1609-5 25 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-5) / 10 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": ["INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR", "INTRASYNOVIAL", "SOFT TISSUE"], "spl_id": "924543a3-d04f-4c44-a2ee-008301b1f620", "openfda": {"upc": ["0370121161059"], "unii": ["43502P7F0P"], "rxcui": ["1358610", "1358617"], "spl_set_id": ["de12f38c-ffa1-4d62-b9cb-238a263f6fea"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-1)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "70121-1609-1", "marketing_start_date": "20231110"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-5)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "70121-1609-5", "marketing_start_date": "20231110"}], "brand_name": "Methylprednisolone acetate", "product_id": "70121-1609_924543a3-d04f-4c44-a2ee-008301b1f620", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70121-1609", "generic_name": "Methylprednisolone acetate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylprednisolone acetate", "active_ingredients": [{"name": "METHYLPREDNISOLONE ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA216502", "marketing_category": "ANDA", "marketing_start_date": "20231110", "listing_expiration_date": "20271231"}