methylprednisolone acetate

Generic: methylprednisolone acetate

Labeler: sportpharm llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

methylprednisolone acetate 40 mg/mL

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-031
Product ID 85766-031_4a2b73a8-c0f9-85f9-e063-6294a90ac52c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210043
Listing Expiration 2027-12-31
Marketing Start 2019-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85766031
Hyphenated Format 85766-031

Supplemental Identifiers

RxCUI
1743779
UNII
43502P7F0P

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 ANDA210043 (source: ndc)
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRASYNOVIAL SOFT TISSUE
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-01) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

85766-031-01 1 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-01) / 1 mL in 1 VIAL, SINGLE-DOSE 85766-031-25 25 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-25) / 1 mL in 1 VIAL, SINGLE-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": "4a2b73a8-c0f9-85f9-e063-6294a90ac52c", "openfda": {"unii": ["43502P7F0P"], "rxcui": ["1743779"], "spl_set_id": ["62f4339a-a971-414d-b407-ef030fe4f989"], "manufacturer_name": ["Sportpharm LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "85766-031-01", "marketing_start_date": "20250807"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "85766-031-25", "marketing_start_date": "20250807"}], "brand_name": "Methylprednisolone acetate", "product_id": "85766-031_4a2b73a8-c0f9-85f9-e063-6294a90ac52c", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "85766-031", "generic_name": "Methylprednisolone acetate", "labeler_name": "Sportpharm LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylprednisolone acetate", "active_ingredients": [{"name": "METHYLPREDNISOLONE ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA210043", "marketing_category": "ANDA", "marketing_start_date": "20190520", "listing_expiration_date": "20271231"}