NDC 68788-7207

PrednisoLONE

Prednisolone

PrednisoLONE is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc. The primary component is Prednisolone.

• Product ID: 68788-7207_faa39491-7d8f-4a57-8379-21d8f1d9d301
• NDC: 68788-7207
• Product Type: Human Prescription Drug
• Proprietary Name: PrednisoLONE
• Generic Name: Prednisolone
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040775
• Labeler Name: Preferred Pharmaceuticals Inc
• Substance Name: PREDNISOLONE
• Active Ingredient Strength: 15 mg/5mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68788-7207-4

480 mL in 1 BOTTLE (68788-7207-4)

• Marketing Start Date: 2018-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-7207-4 [68788720704]

PrednisoLONE SYRUP

• Marketing Category: ANDA
• Application Number: ANDA040775
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-23
• Marketing End Date: 2019-11-12

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISOLONE	15 mg/5mL

OpenFDA Data

• SPL SET ID: faa39491-7d8f-4a57-8379-21d8f1d9d301
• Manufacturer:
  • Preferred Pharmaceuticals Inc
• UNII:
  • 9PHQ9Y1OLM
• RxNorm Concept Unique ID - RxCUI:
  • 283077

Pharmacological Class

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

NDC Crossover Matching brand name "PrednisoLONE" or generic name "Prednisolone"

NDC	Brand Name	Generic Name
0527-5406	PrednisoLONE	Prednisolone
0603-1567	PrednisoLONE	Prednisolone
12634-686	Prednisolone	Prednisolone
21695-365	Prednisolone	Prednisolone
33261-475	Prednisolone	Prednisolone
50090-0655	Prednisolone	Prednisolone
50383-042	Prednisolone	Prednisolone
53217-193	Prednisolone	Prednisolone
58177-910	Prednisolone	Prednisolone
61919-291	PREDNISOLONE	PREDNISOLONE
62135-250	Prednisolone	Prednisolone oral
63187-466	Prednisolone	Prednisolone
63629-1862	Prednisolone	Prednisolone
66116-603	Prednisolone	Prednisolone
67296-1656	Prednisolone	Prednisolone
68258-8987	Prednisolone	Prednisolone
68788-7207	PrednisoLONE	Prednisolone
68788-9096	Prednisolone	Prednisolone
70518-2084	Prednisolone	Prednisolone
23594-505	MILLIPRED	PREDNISOLONE
73534-505	MILLIPRED	PREDNISOLONE
0378-4710	Prednisolone Sodium Phosphate	prednisolone
0378-4715	Prednisolone Sodium Phosphate	prednisolone
0378-4730	Prednisolone Sodium Phosphate	prednisolone