HomeNDC LookupIngredientsSilver Sulfadiazine › 67877-0124-50
Silver sulfadiazine 10 mg/g Cream, 50 g — NDC 67877-0124-50 package photo

Silver sulfadiazine 10 mg/g Cream, 50 g

by Ascend Laboratories, LLC · 50 g in 1 JAR (67877-124-50)
NDC 67877-0124-50
🏷️ FDA NDC (as labeled) 67877-124-50 billing pads the product segment with a zero
This package
Contains50 g Cost per g$0.2551 NADAC Per package$12.76 / 50 g Pack sizes7 compare ↓
Also priced by: Medicaid pays $0.2579/unit · Part D plans $0.2091/unit — full pricing hub ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 67877-124-50
Product NDC 67877-124
11-digit billing NDC 67877012450
NCPDP billing unit GM — per gram (weight)
RxCUI 106351
UNII W46JY43EJR
Application # NDA018810
SPL Set ID b4d6694f-2b0a-4d64-9e05-2fef6d8e60d9
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 1985-12-23
Route TOPICAL
Dosage form CREAM
Substance SILVER SULFADIAZINE
GPI-14 90450030003710
GCN Seq No 007669
GCN 31630
HICL code 003347
Ingredient (HICL) Silver Sulfadiazine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5S
Therapeutic class — specific (HIC3) Topical Sulfonamides
AHFS code 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name SILVER SULFADIAZINE 1% CREAM
FDB brand name Silver Sulfadiazine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 67877-124-50 — 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 → 67877-0124-50. 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

LabelerAscend Laboratories, LLC
Application holderTHEPHARMANETWORK LLC
FDA applicationNDA018810 (NDA)
Labeler code67877
First marketedDec 1985
Product typeHuman Prescription Drug
Portfolio349 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

Label name SILVER SULFADIAZINE 1% CREAM Ingredient Silver Sulfadiazine
📖 What it is MedlinePlus · NLM

Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections of second- and third-degree burns. It kills a wide variety of bacteria. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 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:

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 3 mg / 1 g UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 $0.255 $12.76 / 50 g
Medicaid paysCMS SDUD · 12 mo $0.2579 $12.90 / 50 g
Medicare drug plans payPart D · Q2 2026 $0.2091 $10.46 / 50 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.255 $0.122
▲ Up 109% over the last 24 months.
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/gthis 67877-0124-50 Ascend 50 g $0.255 AB Availability likely
SSD Cream 10 g/1000g 43598-0210-25 Dr 25 g $0.316 AB Availability likely +24%
Silver Sulfadiazine 10 mg/g 59762-0131-00 Mylan 1 tube $0.403 AB Availability likely +58%
Silvadene 10 mg/g 61570-0131-20 Pfizer 1 tube $0.433 AB Availability likely +70%
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/1000g 76420-0208-25 Asclemed 25 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

🏛️
1985
On the market since
Dec 1985
📍
2026
Currently FDA-listed
41 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 67877-0124-50, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
56.8K
Units reimbursed last 4 qtrs
3.2M
Gross reimbursed last 4 qtrs
$822.6K
Avg / prescription
$14.48
Avg / unit
$0.2579
Latest quarter Q4 2025
13.6KRx
Medicaid pays / g
$0.2579
gross reimbursed
vs
NADAC / g
$0.2551
acquisition cost
=
Spread
+$0.0028
+1% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
42% FFS 58% MCO
Fee-for-service · 23,876 Rx Managed care · 32,938 Rx
State Medicaid map
Alaska: 700 units · 95.5 per 100k residents AK Maine: 5,570 units · 399 per 100k residents ME Washington: 24,240 units · 310 per 100k residents WA Idaho: 6,145 units · 313 per 100k residents ID Montana: 3,951 units · 349 per 100k residents MT North Dakota: no data reported ND Minnesota: 10,951 units · 191 per 100k residents MN Wisconsin: 21,100 units · 357 per 100k residents WI Michigan: 160,862 units · 1,603 per 100k residents MI New York: 614,437 units · 3,140 per 100k residents NY Vermont: 3,450 units · 533 per 100k residents VT New Hampshire: 3,250 units · 232 per 100k residents NH Oregon: 27,900 units · 659 per 100k residents OR Nevada: 18,580 units · 582 per 100k residents NV Wyoming: no data reported WY South Dakota: 4,154 units · 452 per 100k residents SD Iowa: 30,825 units · 961 per 100k residents IA Illinois: 129,465 units · 1,032 per 100k residents IL Indiana: 65,720 units · 958 per 100k residents IN Ohio: 109,425 units · 929 per 100k residents OH Pennsylvania: 148,955 units · 1,149 per 100k residents PA New Jersey: 193,116 units · 2,079 per 100k residents NJ Massachusetts: 62,060 units · 886 per 100k residents MA California: 268,014 units · 688 per 100k residents CA Utah: 5,900 units · 173 per 100k residents UT Colorado: 10,625 units · 181 per 100k residents CO Nebraska: 11,663 units · 590 per 100k residents NE Missouri: 57,550 units · 929 per 100k residents MO Kentucky: 93,194 units · 2,059 per 100k residents KY West Virginia: 29,400 units · 1,661 per 100k residents WV Virginia: 89,905 units · 1,031 per 100k residents VA Maryland: 69,620 units · 1,127 per 100k residents MD Connecticut: 55,250 units · 1,528 per 100k residents CT Rhode Island: 24,200 units · 2,210 per 100k residents RI Arizona: 47,580 units · 640 per 100k residents AZ New Mexico: 20,100 units · 951 per 100k residents NM Kansas: 7,600 units · 259 per 100k residents KS Arkansas: 16,575 units · 540 per 100k residents AR Tennessee: 63,600 units · 893 per 100k residents TN North Carolina: 175,960 units · 1,624 per 100k residents NC South Carolina: 56,385 units · 1,049 per 100k residents SC Delaware: 7,050 units · 684 per 100k residents DE Oklahoma: 49,095 units · 1,211 per 100k residents OK Louisiana: 66,460 units · 1,453 per 100k residents LA Mississippi: 16,601 units · 565 per 100k residents MS Alabama: 33,250 units · 651 per 100k residents AL Georgia: 93,285 units · 846 per 100k residents GA D.C.: 8,401 units · 1,237 per 100k residents DC Hawaii: 1,300 units · 90.6 per 100k residents HI Texas: 65,990 units · 216 per 100k residents TX Florida: 84,395 units · 373 per 100k residents FL
Units reimbursed · per 100k residents
90.63,140
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 3,140 /100k
2 Rhode Island 2,210 /100k
3 New Jersey 2,079 /100k
4 Kentucky 2,059 /100k
5 West Virginia 1,661 /100k
6 North Carolina 1,624 /100k
7 Michigan 1,603 /100k
8 Connecticut 1,528 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
50 gs this page67877-0124-50 56,814 Rx · $822,570
50 gs67877-0124-05 25,706 Rx · $394,868
25 gs67877-0124-25 24,425 Rx · $269,330
400 gs67877-0124-40 17,083 Rx · $713,306
85 gs67877-0124-85 13,617 Rx · $263,567
20 gs67877-0124-20 12,577 Rx · $138,830
1000 gs67877-0124-10 No Medicaid data
Drug total (last 4 qtrs): 150,222 Rx · 13,691,290 units · $2,602,472 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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 Per unit Per pack Marketing startStatus
67877-0124-05 50 g in 1 TUBE (67877-124-05) $0.2551 / g $12.76 1985-12-23 Active
67877-0124-10 1000 g in 1 JAR (67877-124-10) 1985-12-23 Active
67877-0124-20 20 g in 1 TUBE (67877-124-20) $0.4027 / g $8.05 1985-12-23 Active
67877-0124-25 25 g in 1 TUBE (67877-124-25) $0.3159 / g $7.90 1985-12-23 Active
67877-0124-40 400 g in 1 JAR (67877-124-40) $0.1265 / g $50.61 1985-12-23 Active
67877-0124-50 You're viewing this 50 g in 1 JAR (67877-124-50) $0.2551 / g $12.76 1985-12-23 Active
67877-0124-85 85 g in 1 TUBE (67877-124-85) $0.2622 / g $22.28 1985-12-23 Active

Per g, this pack runs about 102% above the cheapest pack (400 g, $0.1265 vs $0.2551 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 38% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 67877-0124-50?
NDC 67877-0124-50 contains 50 g — 50 g in 1 jar.
What is the difference between NDC 67877-0124-50 and NDC 67877-0124-20?
Both are Silver sulfadiazine 10 mg/g Cream — the drug itself is identical. NDC 67877-0124-50 is the 50 g package, while NDC 67877-0124-20 is the 20 g package. Per-g NADAC also differs: $0.2551 here vs $0.4027 for the 20 g pack.
What NDC number is used to bill for this package of Silver sulfadiazine 10 mg/g Cream?
Bill NDC 67877-0124-50 — the 11-digit billing format is 67877012450. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 33 words

INDICATIONS AND USAGE Silver sulfadiazine cream, USP 1% 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 175 words

DOSAGE AND ADMINISTRATION 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, USP 1% is then applied under sterile conditions. The burn areas should be covered with silver sulfadiazine cream, USP 1% 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 by 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, USP 1% 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 66 words

CONTRAINDICATIONS Silver sulfadiazine cream, USP 1% 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, USP 1% 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 168 words

WARNINGS 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 including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]; gastrointestinal reactions, hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis.

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, USP 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

🤒 Adverse Reactions 148 words

ADVERSE REACTIONS Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. 1,2,3 Leukopenia 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. An increased 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.

🤰 Pregnancy ~1 min read

PREGNANCY: TERATOGENIC EFFECTS: Pregnancy Category B. A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in silver sulfadiazine cream, USP 1% and has revealed no evidence of harm to the fetus due to silver sulfadiazine. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. (See CONTRAINDICATIONS ) Nursing Mothers. It is not known whether silver sulfadiazine cream, USP 1% is excreted in human milk.

However, sulfonamides are known to be excreted in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus. Because of the possibility for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Geriatric Use.

Of the total number of subjects in clinical studies of silver sulfadiazine cream, USP 1%, seven percent were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Pediatric Use.

Safety and effectiveness in children have not been established. (See CONTRAINDICATIONS )

🧬 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 membrane and cell wall to produce its bactericidal effect.

Results of in Vitro Testing With Silver Sulfadiazine Cream, USP 1% Concentration of Silver Sulfadiazine Number of Sensitive Strains / Total Number of Strains Tested Genus and Species 50 µg/mL 100 µg/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 100/101 100/101 Staphylococcus epidermidis 51/51 51/51 β-Hemolytic Streptococcus 4/4 4/4 Enterococcus species 52/53 52/53 Corynebacterium diphtheriae 2/2 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 65 words

HOW SUPPLIED Silver sulfadiazine cream, USP 1% - white to off-white cream NDC Number Size 67877-124-20 20g tube 67877-124-25 25g tube 67877-124-05 50g tube 67877-124-85 85g tube 67877-124-50 50g jar 67877-124-40400g jar 67877-124-101000g jar Store at room temperature. 15°-30°C (59°-86°F). Manufactured for: Ascend Laboratories, LLC Parsippany, NJ 07054 Manufactured by: Crown Laboratories, Inc.

Johnson City, TN 37604 Product Information : 1-877-272-7901 Revised: DEC 2018 P1840.05

📋 Description 86 words

DESCRIPTION Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula: Silver sulfadiazine cream contains 1% w/w silver sulfadiazine.

The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative. structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.