methylprednisolone acetate

Generic: methylprednisolone acetate

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

methylprednisolone acetate 40 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-313
Product ID 55150-313_adbece8f-9459-445c-8d3a-e9c87a2326b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211930
Listing Expiration 2026-12-31
Marketing Start 2023-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150313
Hyphenated Format 55150-313

Supplemental Identifiers

RxCUI
1358610 1358617
UPC
0355150313013 0355150314010
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 ANDA211930 (source: ndc)
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR SOFT TISSUE
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (55150-313-01) / 10 mL in 1 VIAL, MULTI-DOSE
  • 25 VIAL, MULTI-DOSE in 1 CARTON (55150-313-25) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

55150-313-01 1 VIAL, MULTI-DOSE in 1 CARTON (55150-313-01) / 10 mL in 1 VIAL, MULTI-DOSE 55150-313-25 25 VIAL, MULTI-DOSE in 1 CARTON (55150-313-25) / 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", "SOFT TISSUE"], "spl_id": "adbece8f-9459-445c-8d3a-e9c87a2326b8", "openfda": {"upc": ["0355150313013", "0355150314010"], "unii": ["43502P7F0P"], "rxcui": ["1358610", "1358617"], "spl_set_id": ["a0cbcdb5-f657-49f7-8f86-cc5959d69db0"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (55150-313-01)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-313-01", "marketing_start_date": "20230413"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (55150-313-25)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-313-25", "marketing_start_date": "20230413"}], "brand_name": "Methylprednisolone Acetate", "product_id": "55150-313_adbece8f-9459-445c-8d3a-e9c87a2326b8", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "55150-313", "generic_name": "Methylprednisolone Acetate", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylprednisolone Acetate", "active_ingredients": [{"name": "METHYLPREDNISOLONE ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA211930", "marketing_category": "ANDA", "marketing_start_date": "20230413", "listing_expiration_date": "20261231"}