NDC 71180-002

Eskata

Hydrogen Peroxide

Eskata is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Aclaris Therapeutics, Inc.. The primary component is Hydrogen Peroxide.

• Product ID: 71180-002_03a97001-7d04-427a-9e50-c3bef5db5dc9
• NDC: 71180-002
• Product Type: Human Prescription Drug
• Proprietary Name: Eskata
• Generic Name: Hydrogen Peroxide
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-12-14
• Marketing Category: NDA / NDA
• Application Number: NDA209305
• Labeler Name: Aclaris Therapeutics, Inc.
• Substance Name: HYDROGEN PEROXIDE
• Active Ingredient Strength: 40 mg/100mg
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71180-002-12

12 APPLICATOR in 1 CARTON (71180-002-12) > 520 mg in 1 APPLICATOR

• Marketing Start Date: 2017-12-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71180-002-01 [71180000201]

Eskata SOLUTION

• Marketing Category: NDA
• Application Number: NDA209305
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-14

NDC 71180-002-12 [71180000212]

Eskata SOLUTION

• Marketing Category: NDA
• Application Number: NDA209305
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-14

NDC 71180-002-03 [71180000203]

Eskata SOLUTION

• Marketing Category: NDA
• Application Number: NDA209305
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-14

Drug Details

Active Ingredients

Ingredient	Strength
HYDROGEN PEROXIDE	40 mg/100mg

OpenFDA Data

• SPL SET ID: 52f4cc49-6553-426f-9778-0bd34e31b942
• Manufacturer:
  • Aclaris Therapeutics, Inc.
• UNII:
  • BBX060AN9V
• RxNorm Concept Unique ID - RxCUI:
  • 1993067
  • 251182

NDC Crossover Matching brand name "Eskata" or generic name "Hydrogen Peroxide"

NDC	Brand Name	Generic Name
71180-002	Eskata	Eskata
71180-001	Eskata	Eskata
0924-0171	First Aid Only Hydrogen Peroxide	Hydrogen Peroxide
0363-0267	Hydrogen Peroxide	Hydrogen Peroxide
0363-0268	Hydrogen Peroxide	Hydrogen Peroxide
0363-0871	Hydrogen Peroxide	HYDROGEN PEROXIDE
0404-0001	Hydrogen Peroxide	Hydrogen Peroxide
0869-0871	Hydrogen Peroxide	HYDROGEN PEROXIDE
10202-001	Hydrogen Peroxide	Hydrogen Peroxide
0924-0932	Hydrogen Peroxide Antiseptic	Hydrogen Peroxide
10031-008	MedPak Peroxide Oral Rinse	HYDROGEN PEROXIDE
0126-0083	Peroxyl Mouth Sore Mild Mint	Hydrogen Peroxide
0363-0085	Sore Mouth Cleanser	Hydrogen Peroxide
0869-0462	Sore Mouth Cleanser	Hydrogen Peroxide