NDC 53002-9090

Silver Sulfadiazine

Silver Sulfadiazine

Silver Sulfadiazine is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Silver Sulfadiazine.

• Product ID: 53002-9090_9d3adbe8-dd33-43a3-b46a-191950bf50a9
• NDC: 53002-9090
• Product Type: Human Prescription Drug
• Proprietary Name: Silver Sulfadiazine
• Generic Name: Silver Sulfadiazine
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 1985-12-23
• Marketing Category: NDA / NDA
• Application Number: NDA018810
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: SILVER SULFADIAZINE
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53002-9090-1

25 g in 1 TUBE (53002-9090-1)

• Marketing Start Date: 2017-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-9090-3 [53002909003]

Silver Sulfadiazine CREAM

• Marketing Category: NDA
• Application Number: NDA018810
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-9090-1 [53002909001]

Silver Sulfadiazine CREAM

• Marketing Category: NDA
• Application Number: NDA018810
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-9090-2 [53002909002]

Silver Sulfadiazine CREAM

• Marketing Category: NDA
• Application Number: NDA018810
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SILVER SULFADIAZINE	10 mg/g

OpenFDA Data

• SPL SET ID: c148ead0-aee5-4d47-a9ba-5b549016a685
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • W46JY43EJR
• RxNorm Concept Unique ID - RxCUI:
  • 106351

Pharmacological Class

• Sulfonamide Antibacterial [EPC]
• Sulfonamides [CS]

NDC Crossover Matching brand name "Silver Sulfadiazine" or generic name "Silver Sulfadiazine"

NDC	Brand Name	Generic Name
0440-0124	Silver Sulfadiazine	Silver Sulfadiazine
33261-589	Silver Sulfadiazine	Silver Sulfadiazine
45865-642	Silver Sulfadiazine	Silver Sulfadiazine
49999-185	Silver Sulfadiazine	Silver Sulfadiazine
50090-0607	Silver Sulfadiazine	Silver Sulfadiazine
50090-0717	Silver Sulfadiazine	Silver Sulfadiazine
50090-0763	Silver Sulfadiazine	Silver Sulfadiazine
50090-2152	Silver Sulfadiazine	Silver Sulfadiazine
50436-1240	Silver Sulfadiazine	Silver Sulfadiazine
52959-635	Silver Sulfadiazine	Silver Sulfadiazine
53002-9090	Silver Sulfadiazine	Silver Sulfadiazine
55700-068	Silver Sulfadiazine	Silver Sulfadiazine
59762-0131	SILVER SULFADIAZINE	silver sulfadiazine
61919-206	SILVER SULFADIAZINE	SILVER SULFADAZINE
61919-237	Silver Sulfadiazine	Silver Sulfadiazine
63187-023	Silver Sulfadiazine	Silver Sulfadiazine
67877-124	Silver Sulfadiazine	Silver Sulfadiazine
68071-1334	Silver Sulfadiazine	Silver Sulfadiazine
68071-1333	Silver Sulfadiazine	Silver Sulfadiazine
68071-4481	Silver Sulfadiazine	Silver Sulfadiazine
68387-450	Silver Sulfadiazine	Silver Sulfadiazine
70518-0366	Silver Sulfadiazine	Silver Sulfadiazine
70518-1562	Silver Sulfadiazine	Silver Sulfadiazine
66267-943	Silver Sulfadiazine	Silver Sulfadiazine
49999-143	SILVADENE	silver sulfadiazine
50090-0230	SILVADENE	silver sulfadiazine
61570-131	SILVADENE	silver sulfadiazine
0591-0810	Silver Sulfadiazene	Silver Sulfadiazine
42254-118	Silver Sulfadiazene	Silver Sulfadiazine
50436-3098	Silver Sulfadiazene	Silver Sulfadiazine
50436-3099	Silver Sulfadiazene	Silver Sulfadiazine
43598-210	SSD Cream	Silver Sulfadiazine
50090-2288	SSD Cream	Silver Sulfadiazine
55700-640	SSD Cream	Silver Sulfadiazine
21695-182	Thermazene	Silver Sulfadiazine
53097-101	Thermazene	Silver Sulfadiazine