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Silver Sulfadiazine 10 g/1000g Cream, 50 g

by Asclemed USA, Inc. · 50 g in 1 TUBE (76420-208-50)
NDC 76420-0208-50
🏷️ FDA NDC (as labeled) 76420-208-50 billing pads the product segment with a zero
This package
Contains50 g Pack sizes2 compare ↓
Also priced by: Part D plans $0.2091/unit — full pricing hub ↓
Also comes in: 25 g 76420-0208-25
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 76420-208-50
Product NDC 76420-208
11-digit billing NDC 76420020850
RxCUI 106351
UNII W46JY43EJR
Application # NDA018578
SPL Set ID bee162c3-2627-4f28-9715-11a351d497eb
Established class (EPC) Sulfonamide Antibacterial
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-05-04
Route TOPICAL
Dosage form CREAM
Substance SILVER SULFADIAZINE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 76420-208-50 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76420-0208-50. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Sulfonamide Antibacterial class.

Pharmacologic class Sulfonamide Antibacterial
Drug family (ATC) Sulfonamides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAsclemed USA, Inc.
Application holderDR REDDYS LABORATORIES INC
FDA applicationNDA018578 (NDA)
Labeler code76420
First marketedMay 2011
Product typeHuman Prescription Drug
Portfolio652 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Silver sulfadiazine cream is applied to second- and third-degree burn wounds to help prevent and treat serious infection. It's not a standalone treatment — your care team uses it a...
  • After the wound is cleaned and any dead tissue is removed, the cream is spread in a thin layer — about 1/16 of an inch — directly over the burn area. It's applied once or twice a d...
  • A temporary dip in white blood cells, especially a type called neutrophils, is actually one of the more commonly reported effects — it happens in roughly 1 in 5 patients. The good...
  • My white blood cell count went down — should I be worried?
📖 Read our full Silver Sulfadiazine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Silver Sulfadiazine — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Silver Sulfadiazine (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2091 $10.46 / 50 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Silver sulfadiazine 10 mg/g 67877-0124-05 Ascend 50 g $0.255 AB Availability likely —
SSD Cream 10 g/1000g 43598-0210-25 Dr 25 g $0.316 AB Availability likely —
Silver Sulfadiazine 10 mg/g 59762-0131-00 Mylan 1 tube $0.403 AB Availability likely —
Silvadene 10 mg/g 61570-0131-20 Pfizer 1 tube $0.433 AB Availability likely —
Silvadene 10 mg/g 50090-0230-00 A-S 1 tube — AB FDA listed —
Silver Sulfadiazine 10 mg/g 50090-0607-00 A-S 50 g — AB FDA listed —
Silver Sulfadiazine 10 mg/g 50090-0717-00 A-S 50 g — AB FDA listed —
Silver Sulfadiazine 10 mg/g 50090-0763-00 A-S 25 g — AB FDA listed —
Silver Sulfadiazine 10 mg/g 50090-2152-00 A-S 400 g — AB FDA listed —
Ssd 10 g/1000g 50090-7447-00 A-S 50 g — AB FDA listed —
SSD Cream 10 g/1000g 60760-0962-50 St. 50 g — AB FDA listed —
Silver Sulfadiazine 10 g/1000g 61919-0237-25 DIRECT 25 g — AB FDA listed —
Silver Sulfadiazine 10 mg/g 63187-0023-25 Proficient 25 g — AB FDA listed —
Silver Sulfadiazine 10 mg/g 63629-8768-01 Bryant 20 g — AB Discontinued —
Silver Sulfadiazine 10 mg/g 63629-8769-01 Bryant 25 g — AB Discontinued —
Silver Sulfadiazine 10 mg/g 63629-8770-01 Bryant 50 g — AB Discontinued —
Silver Sulfadiazine 10 mg/g 63629-8771-01 Bryant 50 g — AB Discontinued —
Silver Sulfadiazine 10 mg/g 63629-8772-01 Bryant 85 g — AB Discontinued —
Silver Sulfadiazine 10 mg/g 63629-8773-01 Bryant 400 g — AB Discontinued —
Silver Sulfadiazine 10 g/1000g 68071-2473-05 NuCare 50 g — AB FDA listed —
SSD Cream 10 g/1000g 68071-3867-05 NuCare 50 g — AB FDA listed —
Thermazene Silver Sulfadiazine 10 mg/g 68788-0600-02 Preferred 25 g — AB FDA listed —
SSD Cream 10 g/1000g 68788-8074-02 Preferred 25 g — AB FDA listed —
Silver Sulfadiazine 10 g/1000gthis 76420-0208-50 Asclemed 50 g — AB FDA listed —
Silver Sulfadiazine 10 mg/g 80425-0221-01 Advanced 50 g — AB FDA listed —
Silver Sulfadiazine 10 mg/g 87063-0078-05 Asclemed 50 g — AB FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2011
On the market since
May 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Silver Sulfadiazine — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Silver Sulfadiazine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.77M
Claims incl. refills
136.7K
Beneficiaries
106.4K
Spend / beneficiary
$26.00
Spend / claim
$20.23
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76420-0208-25 25 g in 1 TUBE (76420-208-25) 2022-03-09 Active
76420-0208-50 You're viewing this 50 g in 1 TUBE (76420-208-50) 2022-03-09 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 76420-0208-50?
NDC 76420-0208-50 contains 50 g — 50 g in 1 tube.
What is the difference between NDC 76420-0208-50 and NDC 76420-0208-25?
Both are Silver Sulfadiazine 10 g/1000g Cream — the drug itself is identical. NDC 76420-0208-50 is the 50 g package, while NDC 76420-0208-25 is the 25 g package.
What NDC number is used to bill for this package of Silver Sulfadiazine 10 g/1000g Cream?
Bill NDC 76420-0208-50 — the 11-digit billing format is 76420020850. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 76420-208-50, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76420-0208-50, written without dashes as 76420020850. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76420-0208-50, the first segment (76420) is the labeler code FDA assigned to Asclemed USA, Inc.; the middle segment (0208) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Asclemed USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 25 g (76420-0208-25). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Asclemed USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 31 words ▾

INDICATIONS AND USAGE Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.

⏱️ Dosage and Administration 178 words ▾

DOSAGE AND ADMINISTRATION: FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE: Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided; Silver Sulfadiazine Cream is then applied under sterile conditions. The burn areas should be covered with Silver Sulfadiazine Cream at all times.

The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity. Administration may be accomplished in minimal time because dressings are not required.

However, if individual patient requirements make dressings necessary, they may be used. Reapply immediately after hydrotherapy. Treatment with Silver Sulfadiazine Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting.

The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

⛔ Contraindications 62 words ▾

CONTRAINDICATIONS Silver Sulfadiazine Cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. Because sulfonamide therapy is known to increase the possibility of kernicterus, Silver Sulfadiazine Cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.

⚠️ Warnings 76 words ▾

WARNING There is a potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction. Fungal proliferation in and below the eschar may occur.

However, the incidence of clinically reported fungal superinfection is low. The use of Silver Sulfadiazine Cream in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy. Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within two to four days of initiation of therapy.

Rebound to normal leukocyte levels follows onset within two to three days. Recovery is not influenced by continuation of silver sulfadiazine therapy. The incidence of leucopenia in various reports averages about 20%.

A higher incidence has been seen in patients treated concurrently with cimetidine. Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis.

However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture. Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur.

Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia, hemolytic anemia, dermatologic reactions, allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. Results from in vitro testing are listed below.

Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine. Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell wall to produce its bactericidal effect.

Results of In Vitro Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains / Total Number of Strains Tested Genus and Species 50 micrograms/mL 100 micrograms/mL Pseudomonas Aeruginosa 130/130 130/130 Xanthomonas (Pseudomonas) Maltophilia 7/7 7/7 Enterobacter Species 48/50 50/50 Enterobacter cloacae 24/24 24/24 Klebsiella Species 53/54 54/54 Escherichia Coli 63/63 63/63 Serratia Species 27/28 28/28 Proteus Mirabilis 53/53 53/53 Morganella Morganii 10/10 10/10 Providencia Rettgeri 2/2 2/2 Proteus Vulgaris 2/2 2/2 Providencia Species 1/1 1/1 Citrobacter Species 10/10 10/10 Acinetobacter Calcoaceticus 10/11 11/11 Stahylococcus Aureus 100/101 101/101 Staphylococcus Epidermidis 51/51 51/51 B-Hemolytic Streptococcus 4/4 4/4 Enterococcus Species 52/53 53/53 Corynebacterium Diphtheriae 2/2 2/2 Clostridium Perfringens 0/2 2/2 Clostridium Perfringens 0/2 2/2 Candida Albicans 43/50 50/50 Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

📦 How Supplied / Storage and Handling 56 words ▾

HOW SUPPLIED 1% Silver Sulfadiazine Cream : white to off-white cream. 25 gram tube NDC 76420-208-25 (relabeled from NDC 43598-210-25) 50 gram tube NDC 76420-208-50 (relabeled from NDC 43598-210-50) Store at controlled room temperature 15° - 30°C (59° - 86°F) SSD is a trademark of Dr. Reddy's Laboratories, Inc. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

📋 Description 102 words ▾

DESCRPITION 1% Silver Sulfadiazine Cream are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base. Each 1000 grams of 1% Silver Sulfadiazine Cream contains 10 grams of silver sulfadiazine.

Inactive Ingrediants: cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative. Silver sulfadiazine has an emprical formula of C 10 H 9 AgN 4 O 2 S, molecular weight of 357.14 and structural formula as shown: Structure for silver sulfadiazine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76420-0204-05 · Asclemed 76420-0209-01 · Asclemed →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.