NDC 71384-632

Mydriatic-4

Tropicamide - Proparacine - Phenylephrine - Ketorolac

Mydriatic-4 is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Imprimis Njof, Llc. The primary component is Tropicamide; Ketorolac Tromethamine; Proparacaine Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 71384-632_6e11c346-99d7-e440-e053-2991aa0a79b5
• NDC: 71384-632
• Product Type: Human Prescription Drug
• Proprietary Name: Mydriatic-4
• Generic Name: Tropicamide - Proparacine - Phenylephrine - Ketorolac
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-05-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Imprimis NJOF, LLC
• Substance Name: TROPICAMIDE; KETOROLAC TROMETHAMINE; PROPARACAINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/mL; mg/mL; mg/mL; mg/mL
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC],Local Anesthesia [PE],Local Anesthetic [EPC],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71384-632-05

5 mL in 1 BOTTLE, DROPPER (71384-632-05)

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

NDC SPL Data Element Entries

NDC 71384-632-05 [71384063205]

Mydriatic-4 SOLUTION/ DROPS

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

Drug Details

Active Ingredients

Ingredient	Strength
TROPICAMIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 6e11c346-99d6-e440-e053-2991aa0a79b5
• Manufacturer:
  • Imprimis NJOF, LLC
• UNII:
  • U96OL57GOY
  • N0A3Z5XTC6
  • 04JA59TNSJ
  • 4EVE5946BQ

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Cyclooxygenase Inhibitor [EPC]
• Local Anesthesia [PE]
• Local Anesthetic [EPC]
• alpha-1 Adrenergic Agonist [EPC]
• Adrenergic alpha1-Agonists [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]