NDC 61314-637

Prednisolone Acetate

Prednisolone Acetate

Prednisolone Acetate is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Prednisolone Acetate.

• Product ID: 61314-637_09d17d81-3127-46b9-8553-ffc22e9434a8
• NDC: 61314-637
• Product Type: Human Prescription Drug
• Proprietary Name: Prednisolone Acetate
• Generic Name: Prednisolone Acetate
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1994-12-15
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA017469
• Labeler Name: Sandoz Inc
• Substance Name: PREDNISOLONE ACETATE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 61314-637-05

1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) > 5 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 1994-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61314-637-15 [61314063715]

Prednisolone Acetate SUSPENSION/ DROPS

• Marketing Category: NDA authorized generic
• Application Number: NDA017469
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1994-12-15

NDC 61314-637-10 [61314063710]

Prednisolone Acetate SUSPENSION/ DROPS

• Marketing Category: NDA authorized generic
• Application Number: NDA017469
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1994-12-15

NDC 61314-637-05 [61314063705]

Prednisolone Acetate SUSPENSION/ DROPS

• Marketing Category: NDA authorized generic
• Application Number: NDA017469
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1994-12-15

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISOLONE ACETATE	10 mg/mL

OpenFDA Data

• SPL SET ID: 05d205c7-8f51-46b9-a6c5-4199bc432b26
• Manufacturer:
  • Sandoz Inc.
• UNII:
  • 8B2807733D
• RxNorm Concept Unique ID - RxCUI:
  • 1376336

Pharmacological Class

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

Medicade Reported Pricing

61314063715 PREDNISOLONE AC 1% EYE DROP

Pricing Unit: ML | Drug Type:

61314063710 PREDNISOLONE AC 1% EYE DROP

Pricing Unit: ML | Drug Type:

61314063705 PREDNISOLONE AC 1% EYE DROP

Pricing Unit: ML | Drug Type:

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