silver sulfadiazine

Generic: silver sulfadiazine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name silver sulfadiazine
Generic Name silver sulfadiazine
Labeler mylan pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

silver sulfadiazine 10 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0131
Product ID 59762-0131_1d9744df-203c-419a-9aca-3ca748b09c98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA017381
Listing Expiration 2026-12-31
Marketing Start 2018-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597620131
Hyphenated Format 59762-0131

Supplemental Identifiers

RxCUI
106351
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 silver sulfadiazine (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 (59762-0131-0) / 20 g in 1 TUBE
  • 1 TUBE in 1 CARTON (59762-0131-2) / 25 g in 1 TUBE
  • 400 g in 1 JAR (59762-0131-4)
  • 1 TUBE in 1 CARTON (59762-0131-5) / 50 g in 1 TUBE
  • 50 g in 1 JAR (59762-0131-6)
  • 1 TUBE in 1 CARTON (59762-0131-8) / 85 g in 1 TUBE
source: ndc

Packages (6)

59762-0131-0 1 TUBE in 1 CARTON (59762-0131-0) / 20 g in 1 TUBE 59762-0131-2 1 TUBE in 1 CARTON (59762-0131-2) / 25 g in 1 TUBE 59762-0131-4 400 g in 1 JAR (59762-0131-4) 59762-0131-5 1 TUBE in 1 CARTON (59762-0131-5) / 50 g in 1 TUBE 59762-0131-6 50 g in 1 JAR (59762-0131-6) 59762-0131-8 1 TUBE in 1 CARTON (59762-0131-8) / 85 g in 1 TUBE

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": "1d9744df-203c-419a-9aca-3ca748b09c98", "openfda": {"nui": ["N0000175503", "M0020790"], "unii": ["W46JY43EJR"], "rxcui": ["106351"], "spl_set_id": ["7a6a9590-9983-46ff-ae5c-fe95f4e16cb8"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antibacterial [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (59762-0131-0)  / 20 g in 1 TUBE", "package_ndc": "59762-0131-0", "marketing_start_date": "20180209"}, {"sample": false, "description": "1 TUBE in 1 CARTON (59762-0131-2)  / 25 g in 1 TUBE", "package_ndc": "59762-0131-2", "marketing_start_date": "20180209"}, {"sample": false, "description": "400 g in 1 JAR (59762-0131-4)", "package_ndc": "59762-0131-4", "marketing_start_date": "20180116"}, {"sample": false, "description": "1 TUBE in 1 CARTON (59762-0131-5)  / 50 g in 1 TUBE", "package_ndc": "59762-0131-5", "marketing_start_date": "20180116"}, {"sample": false, "description": "50 g in 1 JAR (59762-0131-6)", "package_ndc": "59762-0131-6", "marketing_start_date": "20180116"}, {"sample": false, "description": "1 TUBE in 1 CARTON (59762-0131-8)  / 85 g in 1 TUBE", "package_ndc": "59762-0131-8", "marketing_start_date": "20180116"}], "brand_name": "SILVER SULFADIAZINE", "product_id": "59762-0131_1d9744df-203c-419a-9aca-3ca748b09c98", "dosage_form": "CREAM", "pharm_class": ["Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "59762-0131", "generic_name": "silver sulfadiazine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILVER SULFADIAZINE", "active_ingredients": [{"name": "SILVER SULFADIAZINE", "strength": "10 mg/g"}], "application_number": "NDA017381", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180115", "listing_expiration_date": "20261231"}