methylprednisolone acetate

Generic: methylprednisolone acetate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

methylprednisolone acetate 80 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-821
Product ID 25021-821_13e1ca54-4fc4-4e93-a52d-c9320865e3cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201835
Listing Expiration 2026-12-31
Marketing Start 2021-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021821
Hyphenated Format 25021-821

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 ANDA201835 (source: ndc)
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRASYNOVIAL SOFT TISSUE
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-821-05) / 5 mL in 1 VIAL
source: ndc

Packages (1)

25021-821-05 1 VIAL in 1 CARTON (25021-821-05) / 5 mL in 1 VIAL

Ingredients (1)

methylprednisolone acetate (80 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": "13e1ca54-4fc4-4e93-a52d-c9320865e3cb", "openfda": {"unii": ["43502P7F0P"], "rxcui": ["1358610", "1358617"], "spl_set_id": ["f98314ea-a4e4-4f78-987b-3e9b45a08bb4"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-821-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-821-05", "marketing_start_date": "20211115"}], "brand_name": "methylprednisolone acetate", "product_id": "25021-821_13e1ca54-4fc4-4e93-a52d-c9320865e3cb", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "25021-821", "generic_name": "methylprednisolone acetate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "methylprednisolone acetate", "active_ingredients": [{"name": "METHYLPREDNISOLONE ACETATE", "strength": "80 mg/mL"}], "application_number": "ANDA201835", "marketing_category": "ANDA", "marketing_start_date": "20211115", "listing_expiration_date": "20261231"}