silvadene

Generic: silver sulfadiazine

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name silvadene
Generic Name silver sulfadiazine
Labeler pfizer laboratories div pfizer inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

silver sulfadiazine 10 mg/g

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 61570-131
Product ID 61570-131_2d9a5dc8-0dfd-42b8-a641-b4b82a113fab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017381
Listing Expiration 2027-12-31
Marketing Start 1973-11-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61570131
Hyphenated Format 61570-131

Supplemental Identifiers

RxCUI
106351 208186
UNII
W46JY43EJR
NUI
N0000175503 M0020790

Packaging Origin

Original Packager
true

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 silvadene (source: ndc)
Generic Name silver sulfadiazine (source: ndc)
Application Number NDA017381 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (61570-131-20) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (61570-131-25) / 25 g in 1 TUBE
  • 400 g in 1 JAR (61570-131-40)
  • 50 g in 1 JAR (61570-131-50)
  • 1 TUBE in 1 CARTON (61570-131-55) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (61570-131-85) / 85 g in 1 TUBE
  • 1000 g in 1 JAR (61570-131-98)
source: ndc

Packages (7)

61570-131-20 1 TUBE in 1 CARTON (61570-131-20) / 20 g in 1 TUBE 61570-131-25 1 TUBE in 1 CARTON (61570-131-25) / 25 g in 1 TUBE 61570-131-40 400 g in 1 JAR (61570-131-40) 61570-131-50 50 g in 1 JAR (61570-131-50) 61570-131-55 1 TUBE in 1 CARTON (61570-131-55) / 50 g in 1 TUBE 61570-131-85 1 TUBE in 1 CARTON (61570-131-85) / 85 g in 1 TUBE 61570-131-98 1000 g in 1 JAR (61570-131-98)

Ingredients (1)

silver sulfadiazine (10 mg/g)

Linked Drug Pages (1)

SILVADENE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2d9a5dc8-0dfd-42b8-a641-b4b82a113fab", "openfda": {"nui": ["N0000175503", "M0020790"], "unii": ["W46JY43EJR"], "rxcui": ["106351", "208186"], "spl_set_id": ["c437213a-1cd4-445e-a39f-bbcacb9f746f"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antibacterial [EPC]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (61570-131-20)  / 20 g in 1 TUBE", "package_ndc": "61570-131-20", "marketing_start_date": "19731126"}, {"sample": false, "description": "1 TUBE in 1 CARTON (61570-131-25)  / 25 g in 1 TUBE", "package_ndc": "61570-131-25", "marketing_start_date": "20150526"}, {"sample": false, "description": "400 g in 1 JAR (61570-131-40)", "package_ndc": "61570-131-40", "marketing_start_date": "19731126"}, {"sample": false, "description": "50 g in 1 JAR (61570-131-50)", "package_ndc": "61570-131-50", "marketing_start_date": "19731126"}, {"sample": false, "description": "1 TUBE in 1 CARTON (61570-131-55)  / 50 g in 1 TUBE", "package_ndc": "61570-131-55", "marketing_start_date": "20150526"}, {"sample": false, "description": "1 TUBE in 1 CARTON (61570-131-85)  / 85 g in 1 TUBE", "package_ndc": "61570-131-85", "marketing_start_date": "19731126"}, {"sample": false, "description": "1000 g in 1 JAR (61570-131-98)", "package_ndc": "61570-131-98", "marketing_start_date": "19731126"}], "brand_name": "SILVADENE", "product_id": "61570-131_2d9a5dc8-0dfd-42b8-a641-b4b82a113fab", "dosage_form": "CREAM", "pharm_class": ["Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "61570-131", "generic_name": "silver sulfadiazine", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILVADENE", "active_ingredients": [{"name": "SILVER SULFADIAZINE", "strength": "10 mg/g"}], "application_number": "NDA017381", "marketing_category": "NDA", "marketing_start_date": "19731126", "listing_expiration_date": "20271231"}