NDC 0299-3839

Rosanil

Sodium Sulfacetamide, Sulfer

Rosanil is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Sulfacetamide; Sulfur.

• Product ID: 0299-3839_81928d4c-2ee7-4313-aa7a-2a228abcdd51
• NDC: 0299-3839
• Product Type: Human Prescription Drug
• Proprietary Name: Rosanil
• Generic Name: Sodium Sulfacetamide, Sulfer
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2003-01-31
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Galderma Laboratories, L.P.
• Substance Name: SULFACETAMIDE; SULFUR
• Active Ingredient Strength: 10 g/100g; g/100g
• Pharm Classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0299-3839-06

1 TUBE in 1 CARTON (0299-3839-06) > 170 g in 1 TUBE

• Marketing Start Date: 2003-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0299-3839-01 [00299383901]

Rosanil SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-01-31
• Marketing End Date: 2014-09-23

NDC 0299-3839-06 [00299383906]

Rosanil SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2003-01-31
• Marketing End Date: 2017-12-31

Drug Details

Active Ingredients

Ingredient	Strength
SULFACETAMIDE	10 g/100g

OpenFDA Data

• SPL SET ID: f72c312a-bd70-1f4a-9a4c-604fcf2372ba
• Manufacturer:
  • Galderma Laboratories, L.P.
• UNII:
  • 70FD1KFU70
  • 4965G3J0F5
• RxNorm Concept Unique ID - RxCUI:
  • 1006057
  • 999613

Pharmacological Class

• Sulfonamide Antibacterial [EPC]
• Sulfonamides [CS]