NDC 71384-505

Pred-Brom

Prednisolone Acetate-bromfenac

Pred-Brom is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Imprimis Njof, Llc. The primary component is Prednisolone Acetate; Bromfenac Sodium.

• Product ID: 71384-505_632b3f47-ae7c-3e64-e053-2991aa0a59f9
• NDC: 71384-505
• Product Type: Human Prescription Drug
• Proprietary Name: Pred-Brom
• Generic Name: Prednisolone Acetate-bromfenac
• Dosage Form: Suspension/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-01-05
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: PREDNISOLONE ACETATE; BROMFENAC SODIUM
• Active Ingredient Strength: 10 mg/mL; mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71384-505-03

20 BOTTLE, DROPPER in 1 BOX (71384-505-03) > 3.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2018-01-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71384-505-03 [71384050503]

Pred-Brom SUSPENSION/ DROPS

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-01-05
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISOLONE ACETATE	10 mg/mL

OpenFDA Data

• SPL SET ID: 63254869-67d5-0900-e053-2a91aa0af95c
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • 8ECV571Y37
  • 8B2807733D

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

NDC Crossover Matching brand name "Pred-Brom" or generic name "Prednisolone Acetate-bromfenac"

NDC	Brand Name	Generic Name
70261-505	Pred-Brom	Prednisolone Acetate-Bromfenac
71384-505	Pred-Brom	Prednisolone Acetate-Bromfenac