NDC 55379-405

Hybrisil

Methylprednisolone Acetate

Hybrisil is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Biozone Laboratories, Inc.. The primary component is Methylprednisolone Acetate.

• Product ID: 55379-405_4e2e9bc4-6ba8-11e0-ae3e-0800200c9a66
• NDC: 55379-405
• Product Type: Human Prescription Drug
• Proprietary Name: Hybrisil
• Generic Name: Methylprednisolone Acetate
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-05-05
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: BioZone Laboratories, Inc.
• Substance Name: METHYLPREDNISOLONE ACETATE
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 55379-405-31

1 BOTTLE, PUMP in 1 CARTON (55379-405-31) > 30 g in 1 BOTTLE, PUMP (55379-405-30)

• Marketing Start Date: 2010-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55379-405-31 [55379040531]

Hybrisil GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-05
• Inactivation Date: 2019-10-29

NDC 55379-405-30 [55379040530]

Hybrisil GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-05

Drug Details

Active Ingredients

Ingredient	Strength
METHYLPREDNISOLONE ACETATE	10 mg/g

OpenFDA Data

• SPL SET ID: f8432414-d8a6-4597-a226-61fd09a80e0c
• Manufacturer:
  • BioZone Laboratories, Inc.
• UNII:
  • 43502P7F0P
• RxNorm Concept Unique ID - RxCUI:
  • 1100391
  • 1100387

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Hybrisil" or generic name "Methylprednisolone Acetate"

NDC	Brand Name	Generic Name
55379-405	Hybrisil	Hybrisil
0009-0274	Depo-Medrol	methylprednisolone acetate
0009-0280	Depo-Medrol	methylprednisolone acetate
0009-0306	Depo-Medrol	methylprednisolone acetate
0009-3073	Depo-Medrol	methylprednisolone acetate
0009-3475	Depo-Medrol	methylprednisolone acetate
0703-0031	Methylprednisolone Acetate	Methylprednisolone Acetate
0703-0043	Methylprednisolone Acetate	Methylprednisolone Acetate
0703-0045	Methylprednisolone Acetate	Methylprednisolone Acetate