methylprednisolone acetate

Generic: methylprednisolone acetate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylprednisolone acetate
Generic Name methylprednisolone acetate
Labeler endo usa, inc.
Dosage Form INJECTION, SUSPENSION
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMENINGEAL SOFT TISSUE
Active Ingredients

methylprednisolone acetate 40 mg/mL

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 42023-238
Product ID 42023-238_9d6bd79b-4885-454e-b127-c5978e501024
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214297
Listing Expiration 2026-12-31
Marketing Start 2023-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023238
Hyphenated Format 42023-238

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 ANDA214297 (source: ndc)
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMENINGEAL SOFT TISSUE
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (42023-238-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

42023-238-01 1 VIAL in 1 CARTON (42023-238-01) / 5 mL in 1 VIAL

Ingredients (1)

methylprednisolone acetate (40 mg/mL)

Linked Drug Pages (1)

METHYLPREDNISOLONE ACETATE, Methylprednisolone Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMENINGEAL", "SOFT TISSUE"], "spl_id": "9d6bd79b-4885-454e-b127-c5978e501024", "openfda": {"unii": ["43502P7F0P"], "rxcui": ["1358610", "1358617"], "spl_set_id": ["631f7d3e-5620-4be3-b918-2f0d38a97890"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (42023-238-01)  / 5 mL in 1 VIAL", "package_ndc": "42023-238-01", "marketing_start_date": "20231102"}], "brand_name": "METHYLPREDNISOLONE ACETATE", "product_id": "42023-238_9d6bd79b-4885-454e-b127-c5978e501024", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "42023-238", "generic_name": "METHYLPREDNISOLONE ACETATE", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPREDNISOLONE ACETATE", "active_ingredients": [{"name": "METHYLPREDNISOLONE ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA214297", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}