NDC 71384-552

Pred Phos - Brom

Prednisolone Phosphate - Bromfenac

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

• Product ID: 71384-552_6e28fdfe-03f5-0c1f-e053-2a91aa0a4bd5
• NDC: 71384-552
• Product Type: Human Prescription Drug
• Proprietary Name: Pred Phos - Brom
• Generic Name: Prednisolone Phosphate - Bromfenac
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-07-02
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: PREDNISOLONE SODIUM PHOSPHATE; 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 71384-552-03

3.5 mL in 1 BOTTLE, DROPPER (71384-552-03)

• Marketing Start Date: 2018-07-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71384-552-03 [71384055203]

Pred Phos - Brom SOLUTION/ DROPS

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-02
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISOLONE SODIUM PHOSPHATE	10 mg/mL

OpenFDA Data

• SPL SET ID: 6e28fdfe-03f4-0c1f-e053-2a91aa0a4bd5
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • IV021NXA9J
  • 8ECV571Y37

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]