NDC 69202-780

Ulesfia

Benzyl Alcohol

Ulesfia is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Lachlan Pharmaceuticals. The primary component is Benzyl Alcohol.

• Product ID: 69202-780_a3735fb1-4657-428a-a341-9a6128967097
• NDC: 69202-780
• Product Type: Human Prescription Drug
• Proprietary Name: Ulesfia
• Generic Name: Benzyl Alcohol
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-08-17
• Marketing End Date: 2020-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA022129
• Labeler Name: Lachlan Pharmaceuticals
• Substance Name: BENZYL ALCOHOL
• Active Ingredient Strength: 50 mg/g
• Pharm Classes: Pediculicide [EPC]
• NDC Exclude Flag: N

Packaging

NDC 69202-780-88

2 BOTTLE, PLASTIC in 1 CARTON (69202-780-88) > 227 g in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2015-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69202-780-08 [69202078008]

Ulesfia LOTION

• Marketing Category: NDA
• Application Number: NDA022129
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-08-17
• Marketing End Date: 2020-03-31

NDC 69202-780-88 [69202078088]

Ulesfia LOTION

• Marketing Category: NDA
• Application Number: NDA022129
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-08-17
• Marketing End Date: 2020-03-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZYL ALCOHOL	50 mg/g

OpenFDA Data

• SPL SET ID: 3dc60601-207d-4da8-9bd3-6f3f3577d231
• Manufacturer:
  • Lachlan Pharmaceuticals
• UNII:
  • LKG8494WBH
• RxNorm Concept Unique ID - RxCUI:
  • 1356673
  • 1356671

Pharmacological Class

• Pediculicide [EPC]

NDC Crossover Matching brand name "Ulesfia" or generic name "Benzyl Alcohol"

NDC	Brand Name	Generic Name
23594-780	Ulesfia	benzyl alcohol
69202-780	Ulesfia	benzyl alcohol
54866-002	AVERTEAX	Benzyl Alcohol
71416-001	Protocoxil	BENZYL ALCOHOL
50486-468	Zilactin	benzyl alcohol
72751-0301	Zilactin	benzyl alcohol