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SULFACETAMIDE SODIUM, SULFUR 50 mg/mL; 100 mg/mL Solution, 355 mL — NDC 81542-0202-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SULFACETAMIDE SODIUM, SULFUR 50 mg/mL; 100 mg/mL Solution, 355 mL — NDC 81542-202-12 (Billing 81542-0202-12)

by Bantry Pharma, LLC · 355 mL in 1 BOTTLE

This is a package of 355 mL of SULFACETAMIDE SODIUM, SULFUR 50 mg/mL; 100 mg/mL Solution from Bantry Pharma, LLC, marketed since Feb 2023 and currently FDA-listed. It is this product's only package size.

NDC 81542-0202-12
🏷️ FDA NDC (as labeled) 81542-202-12 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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 81542-202-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
81542 labeler · 202 product · 12 package
Package marketed since
Feb 8, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
355 mL per package
Barcode (UPC-A, from the NDC)
3 8154220212 2
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81542-202-12
Product NDC 81542-202
11-digit billing NDC 81542020212
NCPDP billing unit ML — per mL (volume)
RxCUI 999613
UNII 70FD1KFU70, 4NRT660KJQ
SPL Set ID f433db67-d8a6-320e-e053-2995a90aab52
Established class (EPC) Sulfonamide Antibacterial
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-08
Route TOPICAL
Dosage form SOLUTION
Substance SULFUR; SULFACETAMIDE SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 059099
GCN 24632
HICL code 034823
Ingredient (HICL) Sulfacetamide Sod/Sulfur/Urea
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 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name SOD SULFACET-SULFUR 10-5% CLSR
FDB brand name Sodium Sulfacetamide-Sulfur
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 059099
  • GCN: 24632
  • HICL (First Databank): 034823
  • AHFS class code: 84:04.92.00
  • RxCUI (RxNorm): 999613
Why two NDCs? The FDA registers this code as 81542-202-12 — 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 → 81542-0202-12. 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) Antiinfectives for treatment of acne, 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

Label name SOD SULFACET-SULFUR 10-5% CLSR Ingredient Sulfacetamide Sod/Sulfur/Urea
🧪 What is this product?

This is a topical solution containing sulfacetamide sodium and sulfur. Sulfacetamide sodium is an antibiotic sulfonamide typically used in skin preparations for bacterial infections, while sulfur is commonly used in dermatologic products for acne and other skin conditions. The combination is applied directly to the skin surface. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
81542-0202-12 You're viewing this Main listing 355 mL in 1 BOTTLE 2023-02-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 58657-0472-06 Method 170 g $0.089 — Availability likely —
Sodium Sulfacetamide 10 Sulfur 5 Cleanser 10 mg/g; 5 mg/g 42192-0136-06 Acella 170.3 g $0.153 — Availability likely —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 69367-0247-06 Westminster 170.3 g $0.153 — Availability likely —
Avar 100 mg/g; 50 mg/g 00178-0480-08 Mission 227 g — — FDA listed —
Sulfacetamide Sodium, Sulfur 50 mg/g; 100 mg/g 24470-0925-08 Cintex 227 g — — FDA listed —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 24470-0953-06 Cintex 170.3 g — — FDA listed —
Sulfacetamide Sodium, Sulfur 100 mg/g; 50 mg/g 44523-0560-08 BioComp 227 g — — FDA listed —
Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser 100 mg/g; 50 mg/g 50405-0850-01 SOHM, 170 g — — FDA listed —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 52187-0536-06 KMM 170.3 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9259-01 Bryant 170 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9260-01 Bryant 170.3 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 63629-9261-01 Bryant 227 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 71335-2940-01 Bryant 227 g — — FDA listed —
Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g; 50 mg/g 71399-0488-06 Akron 170.3 g — — FDA listed —
Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g 72162-1664-02 Bryant 277 g — — FDA listed —
Sulfacetamide Sodium, Sulfur 50 mg/mL; 100 mg/mLthis 81542-0202-12 Bantry 355 ml — — FDA listed —
Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 100 mg/g; 50 mg/g 83720-0547-06 Oncor 170 g — — FDA listed —
Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g 87026-0202-06 Aspen 170 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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.

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

  • 100 mg / 1 mL UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.

1 inactive ingredient 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.

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

LabelerBantry Pharma, LLC
Labeler code81542
First marketedFeb 2023
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Bantry Pharma, LLC labeler code 81542

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

⏱️ Dosage and Administration 62 words ▾

DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.

⛔ Contraindications 32 words ▾

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

⚠️ Warnings 53 words ▾

WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF REACH OF CHILDREN.

🤒 Adverse Reactions 54 words ▾

ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).

🆘 Overdosage 66 words ▾

OVERDOSAGE: The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.

🧬 Clinical Pharmacology 148 words ▾

CLINICAL PHARMACOLOGY: Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp.

However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

📦 How Supplied / Storage and Handling 40 words ▾

HOW SUPPLIED: 12 fl. oz. (355 mL) bottles, NDC 81542-202-12 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Bantry Pharma, LLC 1000 N. West Street, Suite 1200 Wilmington, DE 19801 2200474 [00] Rev. 12/2022

📦 Storage and Handling 118 words ▾

STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat.

The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed.

Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.

📋 Description 143 words ▾

Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: Each mL contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an emlusion base containing 10% urea, benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, lithium magnesium sodium silicate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum.

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.

The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation.

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation.

Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis.

These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.

Avoid contact with eyes, lips and mucous membranes. Drug Interactions: This product is incompatible with silver preparations. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date.

Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.

Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman.

This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.

📄 Package Label / Principal Display Panel 1 words ▾

label

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 Sodium Sulfacetamide-Sulfur (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Sodium Sulfacetamide-Sulfur. 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
$21.7K
Claims incl. refills
79
Beneficiaries
63
Spend / beneficiary
$344.29
Spend / claim
$274.56
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SULFACETAMIDE SODIUM, SULFUR — the ingredient across all brands.

Top reported reactions

Pain9
Nausea7
Anxiety5
Erythema5
Fall5
Hypersensitivity5
Rash5

Age at onset

Adolescent2
Adult15
Elderly3

Reporter sex

114 reports
Male · 31%
Female · 67%
Unknown · 2%

Serious outcomes

Hospitalization21
Disabling3
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 7 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Bantry Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bantry Pharma, LLC 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.
← 81542-0201-08 · Bantry 81551-0377-01 · Clark →
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.