NDC 68071-3867-05 — SSD Cream Silver Sulfadiazine 10 g/1000g Cream, 50 g

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68071-3867-5

Product NDC 68071-3867

11-digit billing NDC 68071386705

RxCUI 106351, 208185

UNII W46JY43EJR

UPC 0368071386752

Application # NDA018578

SPL Set ID 37670ded-5d4a-4e98-e063-6394a90a1571

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

Marketing end 2028-01-31

Route TOPICAL

Dosage form CREAM

Substance SILVER SULFADIAZINE

TE code (Orange Book) AB · RLD · RS

Quick answers

RxCUI (RxNorm): 106351

Why two NDCs? The FDA registers this code as 68071-3867-5 — a 5-4-1 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 package segment → 68071-3867-05. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

📖 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

It is used along with other burn care to help prevent and treat serious infection in second- and third-degree burns. It is a topical antimicrobial that goes on the skin only.
The burn is cleaned first, and then the cream is applied under sterile conditions in a thin layer, usually once or twice a day. Keep the burn covered with cream and reapply if it r...
Some people notice burning, rash or skin color changes. Your white blood cell count can also dip temporarily, usually in the first few days. Call your doctor if you notice anything...
Get help for widespread rash, blistering or peeling skin, or signs of a serious allergic reaction. Also report unusual bruising or bleeding, frequent infections, or signs of liver...

📖 Read our full Silver Sulfadiazine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

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 system	Per g	Per 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	$0.2130	$10.65 / 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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
68071-3867-05 You're viewing this Main listing	50 g in 1 TUBE	2025-06-13	Jan 31, 2028	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Silver sulfadiazine 10 mg/g 67877-0124-05	Ascend	50 g	$0.260	AB	Availability likely	—
SSD Cream 10 g/1000g 43598-0210-25	Dr	25 g	$0.318	AB	Availability likely	—
Silver Sulfadiazine 10 mg/g 59762-0131-00	Mylan	1 tube	$0.407	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/1000gthis 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

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.

FDA Orange Book · refreshed Sep 3, 2026

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 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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.
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.

9 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 DailyMed — ingredient 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.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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.

Manufacturer & labeler

LabelerNuCare Pharmaceuticals, Inc.

Application holderDR REDDYS LABORATORIES INC

FDA applicationNDA018578 (NDA)

Labeler code68071

First marketedMay 2011

Product typeHuman Prescription Drug

Portfolio365 products on file

🔎 All NDCs from NuCare Pharmaceuticals, Inc.

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 ⚠️ Precautions 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel

🎯 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 51 words ▾

HOW SUPPLIED SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram tube NDC 68071-3867-5 Store at controlled room temperature 15° - 30°C (59° - 86°F) SSD is a trademark of Dr. Reddy's Laboratories, Inc. Manufactured by: Dr. Reddy's Laboratories Louisiana LLC Shreveport, LA 71106 USA Revised, June 2013

📋 Description 113 words ▾

DESCRPITION SSD™ (1% Silver Sulfadiazine Cream) and SSD AF™ (1% Silver Sulfadiazine Cream), 1% 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 SSD/SSD AF Cream contains 10 grams of silver sulfadiazine.

Inactive Ingrediants: cetyl alcohol (SSD Cream only), 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

⚠️ Precautions 133 words ▾

PRECAUTION If hepatic and renal functions become impaired and elimination of the drug decreases accumulation may occur and discontinuation of Silver Sulfadiazine Cream should be weighed against the therapeutic benefit being achieved. In considering the use of topical proteolytic enzymes in conjunction with Silver Sulfadiazine Cream, the possibility should be noted that silver may inactivate such enzymes. Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12mg %).

Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals. Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 216 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in Silver Sulfadiazine Cream revealed no evidence of carcinogenicity. Pregnancy: 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 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 Mother: It is not known whether Silver Sulfadiazine Cream 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 potential 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. Pediatric Use: Safety and effectiveness in children have not been established.

(See CONTRAINDICATIONS )

📄 Package Label / Principal Display Panel 7 words ▾

Container Label for 50 g Tube pdp

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

bactericidal: Describes a medicine that kills bacteria outright.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

colonization: When germs live on or inside the body without causing illness or symptoms.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cross-sensitivity: The chance that someone allergic to one substance will also react to another, closely related substance.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

fertility: The natural ability to become pregnant or to father a child.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutrophil: A type of white blood cell that is one of the body's main defenders against infection.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

rebound: The return of symptoms, sometimes worse than before, after a medicine that was controlling them is stopped.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

superinfection: A new, second infection that appears during treatment of the first one, often caused by germs the medicine does not kill.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

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

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

Medicare Part D (outpatient prescription) spending for Silver Sulfadiazine (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. 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.

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	✓ Available
Inactive ingredients (structured)	✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but NuCare Pharmaceuticals, Inc. has reported a marketing end date of 2028-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.

Who lists this product with the FDA?

NuCare Pharmaceuticals, 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.

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