NDC 10631-101

Exelderm

Sulconazole Nitrate

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

• Product ID: 10631-101_1e0ce696-fd2c-42fa-80bd-e047ef9f880b
• NDC: 10631-101
• Product Type: Human Prescription Drug
• Proprietary Name: Exelderm
• Generic Name: Sulconazole Nitrate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA018737
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: SULCONAZOLE NITRATE
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10631-101-15

15 g in 1 TUBE (10631-101-15)

• Marketing Start Date: 2010-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10631-101-60 [10631010160]

Exelderm CREAM

• Marketing Category: NDA
• Application Number: NDA018737
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2010-02-01

NDC 10631-101-30 [10631010130]

Exelderm CREAM

• Marketing Category: NDA
• Application Number: NDA018737
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2010-02-01

NDC 10631-101-15 [10631010115]

Exelderm CREAM

• Marketing Category: NDA
• Application Number: NDA018737
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2010-02-01

Drug Details

Active Ingredients

Ingredient	Strength
SULCONAZOLE NITRATE	10 mg/g

OpenFDA Data

• SPL SET ID: 9b963f0d-b041-43be-9434-7161eab49adb
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • 1T89100D5U
• RxNorm Concept Unique ID - RxCUI:
  • 106366
  • 208117
• UPC Code:
  • 0310631101305

Pharmacological Class

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

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