silver sulfadiazine

Generic: silver sulfadiazine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name silver sulfadiazine
Generic Name silver sulfadiazine
Labeler asclemed usa, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

silver sulfadiazine 10 mg/g

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 87063-078
Product ID 87063-078_4908298d-e389-9450-e063-6394a90a5e75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018810
Listing Expiration 2027-12-31
Marketing Start 1985-12-23

Pharmacologic Class

Established (EPC)
sulfonamide antibacterial [epc]
Chemical Structure
sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 87063078
Hyphenated Format 87063-078

Supplemental Identifiers

RxCUI
106351
UNII
W46JY43EJR
NUI
N0000175503 M0020790

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name silver sulfadiazine (source: ndc)
Generic Name silver sulfadiazine (source: ndc)
Application Number NDA018810 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 50 g in 1 TUBE (87063-078-05)
  • 1000 g in 1 JAR (87063-078-10)
  • 20 g in 1 TUBE (87063-078-20)
  • 25 g in 1 TUBE (87063-078-25)
  • 400 g in 1 JAR (87063-078-40)
  • 50 g in 1 JAR (87063-078-50)
  • 85 g in 1 TUBE (87063-078-85)
source: ndc

Packages (7)

87063-078-05 50 g in 1 TUBE (87063-078-05) 87063-078-10 1000 g in 1 JAR (87063-078-10) 87063-078-20 20 g in 1 TUBE (87063-078-20) 87063-078-25 25 g in 1 TUBE (87063-078-25) 87063-078-40 400 g in 1 JAR (87063-078-40) 87063-078-50 50 g in 1 JAR (87063-078-50) 87063-078-85 85 g in 1 TUBE (87063-078-85)

Ingredients (1)

silver sulfadiazine (10 mg/g)

Linked Drug Pages (1)

Silver Sulfadiazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4908298d-e389-9450-e063-6394a90a5e75", "openfda": {"nui": ["N0000175503", "M0020790"], "unii": ["W46JY43EJR"], "rxcui": ["106351"], "spl_set_id": ["4d9aa72e-b8dc-4ea3-be44-80f03ba81982"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antibacterial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 g in 1 TUBE (87063-078-05)", "package_ndc": "87063-078-05", "marketing_start_date": "20260123"}, {"sample": false, "description": "1000 g in 1 JAR (87063-078-10)", "package_ndc": "87063-078-10", "marketing_start_date": "20260123"}, {"sample": false, "description": "20 g in 1 TUBE (87063-078-20)", "package_ndc": "87063-078-20", "marketing_start_date": "20260123"}, {"sample": false, "description": "25 g in 1 TUBE (87063-078-25)", "package_ndc": "87063-078-25", "marketing_start_date": "20260123"}, {"sample": false, "description": "400 g in 1 JAR (87063-078-40)", "package_ndc": "87063-078-40", "marketing_start_date": "20260123"}, {"sample": false, "description": "50 g in 1 JAR (87063-078-50)", "package_ndc": "87063-078-50", "marketing_start_date": "20260123"}, {"sample": false, "description": "85 g in 1 TUBE (87063-078-85)", "package_ndc": "87063-078-85", "marketing_start_date": "20260123"}], "brand_name": "Silver Sulfadiazine", "product_id": "87063-078_4908298d-e389-9450-e063-6394a90a5e75", "dosage_form": "CREAM", "pharm_class": ["Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "87063-078", "generic_name": "Silver Sulfadiazine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Silver Sulfadiazine", "active_ingredients": [{"name": "SILVER SULFADIAZINE", "strength": "10 mg/g"}], "application_number": "NDA018810", "marketing_category": "NDA", "marketing_start_date": "19851223", "listing_expiration_date": "20271231"}