NDC 71384-631

Mydriatic-3

Tropicamide - Cyclopentolate - Phenylephrine

Mydriatic-3 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; Cyclopentolate Hydrochloride; Phenylephrine Hydrochloride.

• Product ID: 71384-631_6bb82e43-57f7-172e-e053-2991aa0a2e6e
• NDC: 71384-631
• Product Type: Human Prescription Drug
• Proprietary Name: Mydriatic-3
• Generic Name: Tropicamide - Cyclopentolate - Phenylephrine
• 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; CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/mL; mg/mL; mg/mL
• Pharm Classes: alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71384-631-05

5 mL in 1 BOTTLE, DROPPER (71384-631-05)

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

NDC SPL Data Element Entries

NDC 71384-631-05 [71384063105]

Mydriatic-3 SOLUTION/ DROPS

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-05-01
• Marketing End Date: 2019-07-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-12

Drug Details

Active Ingredients

Ingredient	Strength
TROPICAMIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 6bb82e43-57f6-172e-e053-2991aa0a2e6e
• Manufacturer:
  • Imprimis NJOF LLC
• UNII:
  • 736I6971TE
  • 04JA59TNSJ
  • N0A3Z5XTC6

Pharmacological Class

• alpha-1 Adrenergic Agonist [EPC]
• Adrenergic alpha1-Agonists [MoA]
• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]