50090-0230 NDC - SILVADENE (SILVER SULFADIAZINE)

Drug Information

  • Product NDC: 50090-0230
  • Proprietary Name: SILVADENE
  • Non Proprietary Name: silver sulfadiazine
  • Active Ingredient(s): 10 mg/g SILVER SULFADIAZINE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM
  • Pharmacy Class(es): Sulfonamide Antibacterial [EPC]; Sulfonamides [CS]

Labeler Information

Field Name Field Value
Labeler Name: A-S Medication Solutions
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA017381
Marketing Category: NDA
Start Marketing Date:11/26/1973

Package Information

No. Package Code Package Description Billing Unit
150090-0230-01 TUBE in 1 CARTON (50090-0230-0) / 20 g in 1 TUBEGM

NDC Record

Field Name Field Value Definition
PRODUCT NDC50090-0230The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMESILVADENEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEsilver sulfadiazineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
DOSAGE FORM NAMECREAMThis is the date that the labeler indicates was the start of its marketing of the drug product.
ROUTE NAMETOPICALThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
START MARKETING DATE11/26/1973Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA017381This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEA-S Medication SolutionsName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESILVER SULFADIAZINEThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/g 
PHARM CLASSESSulfonamide Antibacterial [EPC], Sulfonamides [CS] 

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This page was last updated on: 11/21/2025

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