NDC 0023-0106

PRED-G

Gentamicin, Prednisolone Acetate

PRED-G is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Gentamicin; Prednisolone Acetate.

• Product ID: 0023-0106_b0a11a7a-ecdb-4c31-a128-f82afefe50a0
• NDC: 0023-0106
• Product Type: Human Prescription Drug
• Proprietary Name: PRED-G
• Generic Name: Gentamicin, Prednisolone Acetate
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1990-02-19
• Marketing Category: NDA / NDA
• Application Number: NDA050586
• Labeler Name: Allergan, Inc.
• Substance Name: GENTAMICIN; PREDNISOLONE ACETATE
• Active Ingredient Strength: 3 mg/mL; mg/mL
• Pharm Classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0023-0106-05

1 BOTTLE, DROPPER in 1 CARTON (0023-0106-05) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 1990-02-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-0106-05 [00023010605]

PRED-G SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA050586
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1990-02-19

NDC 0023-0106-02 [00023010602]

PRED-G SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA050586
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-02-19
• Marketing End Date: 2011-07-27

NDC 0023-0106-10 [00023010610]

PRED-G SUSPENSION/ DROPS

• Marketing Category: NDA
• Application Number: NDA050586
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-02-19
• Marketing End Date: 1990-02-19

Drug Details

Active Ingredients

Ingredient	Strength
GENTAMICIN	3 mg/mL

OpenFDA Data

• SPL SET ID: 4e8dd668-bf83-4479-9cb9-88250bb6ef84
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 8B2807733D
  • T6Z9V48IKG
• RxNorm Concept Unique ID - RxCUI:
  • 310469
  • 205826

Pharmacological Class

• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Aminoglycoside Antibacterial [EPC]
• Aminoglycosides [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "PRED-G" or generic name "Gentamicin, Prednisolone Acetate"

NDC	Brand Name	Generic Name
0023-0066	PRED-G	gentamicin sulfate and prednisolone acetate
0023-0106	PRED-G	gentamicin, prednisolone acetate