NDC 52817-800

Clotrimazole Topical Solution USP, 1%

Clotrimazole Topical Solution Usp, 1%

Clotrimazole Topical Solution USP, 1% is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Trupharma Llc. The primary component is Clotrimazole.

• Product ID: 52817-800_1d2354f2-edfd-4be7-9550-760958eb36ee
• NDC: 52817-800
• Product Type: Human Prescription Drug
• Proprietary Name: Clotrimazole Topical Solution USP, 1%
• Generic Name: Clotrimazole Topical Solution Usp, 1%
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-07-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA212281
• Labeler Name: TruPharma LLC
• Substance Name: CLOTRIMAZOLE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52817-800-30

1 BOTTLE in 1 CARTON (52817-800-30) > 30 mL in 1 BOTTLE

• Marketing Start Date: 2019-07-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52817-800-30 [52817080030]

Clotrimazole Topical Solution USP, 1% SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA212281
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-07-25

Drug Details

Active Ingredients

Ingredient	Strength
CLOTRIMAZOLE	10 mg/mL

OpenFDA Data

• SPL SET ID: 1d2354f2-edfd-4be7-9550-760958eb36ee
• Manufacturer:
  • TruPharma LLC
• UNII:
  • G07GZ97H65
• RxNorm Concept Unique ID - RxCUI:
  • 309370

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "Clotrimazole Topical Solution USP, 1%" or generic name "Clotrimazole Topical Solution Usp, 1%"

NDC	Brand Name	Generic Name
52817-800	Clotrimazole Topical Solution USP, 1%	Clotrimazole Topical Solution USP, 1%
72641-001	Clotrimazole Topical Solution USP, 1%	Clotrimazole Topical Solution USP, 1%