NDC 52959-265

PREDNISOLONE ACETATE

Prednisolone Acetate

PREDNISOLONE ACETATE is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Prednisolone Acetate.

• Product ID: 52959-265_fceefb90-8d05-40f0-b612-107685339aff
• NDC: 52959-265
• Product Type: Human Prescription Drug
• Proprietary Name: PREDNISOLONE ACETATE
• Generic Name: Prednisolone Acetate
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1997-08-19
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA017011
• Labeler Name: H.J. Harkins Company, Inc.
• Substance Name: PREDNISOLONE ACETATE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 52959-265-05

5 mL in 1 BOTTLE, DROPPER (52959-265-05)

• Marketing Start Date: 1997-08-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52959-265-05 [52959026505]

PREDNISOLONE ACETATE SUSPENSION/ DROPS

• Marketing Category: NDA authorized generic
• Application Number: NDA017011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-08-19
• Inactivation Date: 2019-11-13

NDC 52959-265-10 [52959026510]

PREDNISOLONE ACETATE SUSPENSION/ DROPS

• Marketing Category: NDA authorized generic
• Application Number: NDA017011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-08-19
• Inactivation Date: 2019-11-13

NDC 52959-265-15 [52959026515]

PREDNISOLONE ACETATE SUSPENSION/ DROPS

• Marketing Category: NDA authorized generic
• Application Number: NDA017011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-08-19
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISOLONE ACETATE	10 mg/mL

OpenFDA Data

• SPL SET ID: c77597c4-8add-4d2a-b8c1-e526cbe22dcb
• Manufacturer:
  • H.J. Harkins Company, Inc.
• UNII:
  • 8B2807733D
• RxNorm Concept Unique ID - RxCUI:
  • 1376336

Pharmacological Class

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

NDC Crossover Matching brand name "PREDNISOLONE ACETATE" or generic name "Prednisolone Acetate"

NDC	Brand Name	Generic Name
50090-0559	Prednisolone Acetate	Prednisolone Acetate
50090-0561	Prednisolone Acetate	Prednisolone Acetate
50090-1912	PREDNISOLONE ACETATE	prednisolone acetate
50090-5275	PREDNISOLONE ACETATE	prednisolone acetate
52959-265	PREDNISOLONE ACETATE	prednisolone acetate
60758-119	PREDNISOLONE ACETATE	prednisolone acetate
61314-637	Prednisolone Acetate	Prednisolone Acetate
68071-1722	PREDNISOLONE ACETATE	prednisolone acetate
68071-2222	PREDNISOLONE ACETATE	prednisolone acetate
72189-055	PREDNISOLONE ACETATE	PREDNISOLONE ACETATE
76420-204	PREDNISOLONE ACETATE	prednisolone acetate
51672-1338	Flo-Pred	Prednisolone Acetate
0065-0638	OMNIPRED	prednisolone acetate
11980-180	PRED FORTE	prednisolone acetate
11980-174	PRED MILD	prednisolone acetate