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Silver Sulfadiazine 10 g/1000g Cream, 50 g — NDC 76420-208-50 (Billing 76420-0208-50)

by Asclemed USA, Inc. · 50 g in 1 TUBE

This is a package of 50 g of Silver Sulfadiazine 10 g/1000g Cream from Asclemed USA, Inc., marketed since May 2011 and currently FDA-listed.

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 ↓
Product page 76420-0208-25 Also comes in: 25 g 76420-208-25
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 76420-208-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
76420 labeler · 208 product · 50 package
Package marketed since
Mar 9, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7642020850 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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
Quick answers
  • RxCUI (RxNorm): 106351
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.

Clinical

📗 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 →

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76420-0208-25 76420-208-25 Main listing 25 g in 1 TUBE 2022-03-09 — Active
76420-0208-50 You're viewing this 50 g in 1 TUBE 2022-03-09 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 50 g — 50 g in 1 tube.
How does this package differ from NDC 76420-0208-25?
Both are Silver Sulfadiazine 10 g/1000g Cream — the drug itself is identical. This page's package is the 50 g one, 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?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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/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.

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.

🧪 Avoiding an ingredient? See Silver Sulfadiazine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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.

Manufacturer & labeler

LabelerAsclemed USA, Inc.
Application holderDR REDDYS LABORATORIES INC
FDA applicationNDA018578 (NDA)
Labeler code76420
First marketedMay 2011
Product typeHuman Prescription Drug
Portfolio653 products on file

More NDCs from Asclemed USA, Inc. labeler code 76420

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.

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 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

⚠️ 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 18 words ▾

Container Label for 25 g Tube Silver Sulfadiazine 1%

Container Label for 50 g Tube Silver Sulfadiazine 1%

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 — 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.

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 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: 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.
← 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.