NDC 10631-100

Exelderm

Sulconazole Nitrate

Exelderm is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Sulconazole Nitrate.

• Product ID: 10631-100_4df88789-d3b0-4082-bb03-a12f9113d48b
• NDC: 10631-100
• Product Type: Human Prescription Drug
• Proprietary Name: Exelderm
• Generic Name: Sulconazole Nitrate
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2009-04-08
• Marketing End Date: 2020-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA018738
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: SULCONAZOLE NITRATE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N

Packaging

NDC 10631-100-30

30 mL in 1 BOTTLE, PLASTIC (10631-100-30)

• Marketing Start Date: 2009-04-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10631-100-30 [10631010030]

Exelderm SOLUTION

• Marketing Category: NDA
• Application Number: NDA018738
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-04-08

NDC 10631-100-04 [10631010004]

Exelderm SOLUTION

• Marketing Category: NDA
• Application Number: NDA018738
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-04-08

NDC 10631-100-32 [10631010032]

Exelderm SOLUTION

• Marketing Category: NDA
• Application Number: NDA018738
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-04-08
• Marketing End Date: 2012-05-05

Drug Details

Active Ingredients

Ingredient	Strength
SULCONAZOLE NITRATE	10 mg/mL

OpenFDA Data

• SPL SET ID: b3aea089-3961-43ea-8335-8128e9bae13b
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • 1T89100D5U
• RxNorm Concept Unique ID - RxCUI:
  • 208118
  • 313125
• UPC Code:
  • 0310631100308

Pharmacological Class

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

Medicade Reported Pricing

10631010030 EXELDERM 1% SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Exelderm" or generic name "Sulconazole Nitrate"

NDC	Brand Name	Generic Name
10631-100	Exelderm	sulconazole nitrate
10631-101	Exelderm	sulconazole nitrate
69489-711	Exelderm	Sulconazole Nitrate
69489-721	Exelderm	Sulconazole Nitrate
72143-311	Sulconazole Nitrate	Sulconazole Nitrate
72143-321	Sulconazole Nitrate	Sulconazole Nitrate