NDC 0065-0325

EMADINE

Emedastine Difumarate

EMADINE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Emedastine Difumarate.

• Product ID: 0065-0325_67f002cc-f6d9-4f75-ba05-7021086a21dd
• NDC: 0065-0325
• Product Type: Human Prescription Drug
• Proprietary Name: EMADINE
• Generic Name: Emedastine Difumarate
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1998-02-15
• Marketing Category: NDA / NDA
• Application Number: NDA020706
• Labeler Name: Alcon Laboratories, Inc.
• Substance Name: EMEDASTINE DIFUMARATE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0065-0325-05

1 BOTTLE, PLASTIC in 1 CARTON (0065-0325-05) > 5 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 1998-02-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0065-0325-05 [00065032505]

EMADINE SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA020706
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1998-02-15

NDC 0065-0325-25 [00065032525]

EMADINE SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA020706
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1998-02-15
• Marketing End Date: 2011-07-13

Drug Details

Active Ingredients

Ingredient	Strength
EMEDASTINE DIFUMARATE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 98a010d5-4905-4abf-a9d2-c85a07daa23b
• Manufacturer:
  • Alcon Laboratories, Inc.
• UNII:
  • 42MB94QOSM
• RxNorm Concept Unique ID - RxCUI:
  • 213204
  • 310056

Pharmacological Class

• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Inhibitor [EPC]