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    NDC 42582-0801-11 Sodium Sulfacetamide 9.8%, Sulfur 4.8% 98; 48 mg/g; mg/g Details

    Sodium Sulfacetamide 9.8%, Sulfur 4.8% 98; 48 mg/g; mg/g

    Sodium Sulfacetamide 9.8%, Sulfur 4.8% is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bi-Coastal Pharma International LLC. The primary component is SULFACETAMIDE SODIUM; SULFUR.

    Product Information

    NDC 42582-0801
    Product ID 42582-801_07dceb9e-e993-494f-86fc-7389bd8d735c
    Associated GPIs 90059903200917
    GCN Sequence Number 072168
    GCN Sequence Number Description sulfacetamide sodium/sulfur CLEANSER 9.8%-4.8% TOPICAL
    HIC3 Q5S
    HIC3 Description TOPICAL SULFONAMIDES
    GCN 36287
    HICL Sequence Number 003344
    HICL Sequence Number Description SULFACETAMIDE SODIUM/SULFUR
    Brand/Generic Generic
    Proprietary Name Sodium Sulfacetamide 9.8%, Sulfur 4.8%
    Proprietary Name Suffix n/a
    Non-Proprietary Name Sodium Sulfacetamide, Sulfur
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route TOPICAL
    Active Ingredient Strength 98; 48
    Active Ingredient Units mg/g; mg/g
    Substance Name SULFACETAMIDE SODIUM; SULFUR
    Labeler Name Bi-Coastal Pharma International LLC
    Pharmaceutical Class Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
    DEA Schedule n/a
    Marketing Category UNAPPROVED DRUG OTHER
    Application Number n/a
    Listing Certified Through 2023-12-31

    Package

    NDC 42582-0801-11 (42582080111)

    NDC Package Code 42582-801-11
    Billing NDC 42582080111
    Package 285 g in 1 BOTTLE (42582-801-11)
    Marketing Start Date 2017-03-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 504e6349-81ef-44a9-8fb6-ec1c4d1c32e8 Details

    Revised: 1/2022