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Dapsone 75 mg/g Gel — NDC 70771-1538-02 package photo

Dapsone 75 mg/g Gel

by Zydus Lifesciences Limited · 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP
NDC 70771-1538-02
🏷️ FDA NDC (as labeled) 70771-1538-2 billing pads the package segment with a zero
This package
Contains30 g in 1 bottle, pump Pack sizes3 compare ↓
Also comes in: 60 g 70771-1538-03 90 g 70771-1538-08
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Dapsone (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 10, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0172-2025
Class II · Dec 10, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0171-2025
Class II · Oct 29, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0038-2025
Class II · Sep 24, 2024 — Crystallization (VIONA PHARMACEUTICALS INC) · FDA recall D-0011-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70771-1538-2
Product NDC 70771-1538
11-digit billing NDC 70771153802
RxCUI 1741905
UNII 8W5C518302
Application # ANDA214019
SPL Set ID 8b63b653-0507-4f95-9bfa-70fd071e15a6
Established class (EPC) Sulfone
Chemical class Sulfones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-10
Route TOPICAL
Dosage form GEL
Substance DAPSONE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70771-1538-2 — 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 → 70771-1538-02. 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 Sulfone class.

Pharmacologic class Sulfone
Drug family (ATC) Other anti-acne preparations for topical use, Drugs for treatment of lepra
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

LabelerZydus Lifesciences Limited
Application holderZYDUS LIFESCIENCES GLOBAL FZE
FDA applicationANDA214019 (ANDA)
Labeler code70771
First marketedMay 2024
Product typeHuman Prescription Drug
Portfolio717 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the form. The dapsone tablet is used to treat leprosy and a blistering, itchy skin condition called dermatitis herpetiformis. The topical gel — including Aczone Gel —...
  • Gently wash your face and pat it dry first. Then squeeze out about a pea-sized amount of Aczone Gel, 7.5% and apply a thin layer across your whole face once a day. You can also app...
  • With the gel, the most common ones are mild — some dryness, oiliness, peeling, or redness where you apply it. One thing to know: if you also use a benzoyl peroxide product, applyin...
  • What side effects should I watch out for?
📖 Read our full Dapsone guide →
7
Nutrient depletion considerations

Dapsone may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dapsone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 20R035KLCI
    A synthetic polymer used as a thickener and gelling agent. In medicines, it helps create the proper texture and consistency of gels, creams, or solutions, and may help control how quickly the active ingredient is released.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 2T9Q6EKI0G
    A synthetic polymer derived from acrylic acid, sodium acryloyldimethyltaurate functions as a thickener and stabilizer in liquid formulations. It helps maintain consistent texture and prevents separation of ingredients in creams, gels, and lotions.
  • 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.

7 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.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · 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.
Try another pack size: 60 g 90 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dapsone 75 mg/g 00378-4830-60 Mylan 1 bottle $0.729 AB Availability likely —
dapsone 75 mg/g 13668-0605-05 Torrent 1 bottle $0.729 AB Availability likely —
Dapsone 75 mg/g 16714-0975-01 NORTHSTAR 1 bottle $0.729 AB Availability likely —
Dapsone 75 mg/g 68308-0342-60 Mayne 1 bottle $0.729 AB Availability likely —
Dapsone 75 mg/g 69238-1627-06 Amneal 1 bottle $0.729 AB Availability likely —
Aczone 75 mg/g 16110-0526-30 Almirall, 1 bottle — AB Discontinued —
Dapsone 75 mg/g 46708-0663-30 Alembic 1 bottle — AB FDA listed —
Dapsone 75 mg/g 51672-1388-02 Sun 1 bottle — AB FDA listed —
Dapsone 75 mg/g 52817-0832-60 Trupharma, 1 tube — AB FDA listed —
Dapsone 75 mg/g 62332-0663-30 Alembic 1 bottle — AB FDA listed —
Dapsone 75 mg/gthis 70771-1538-02 Zydus 1 bottle — AB FDA listed —
Dapsone 75 mg/g 72578-0094-01 Viona 1 bottle — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

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

Medicare Part D (outpatient prescription) spending for Dapsone — the program that covers self-administered drugs. 14 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 Dapsone. 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
$1.61M
Claims incl. refills
22.8K
Beneficiaries
14.4K
Spend / beneficiary
$111.86
Spend / claim
$70.63
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 Dapsone — the ingredient across all brands.

Top reported reactions

Nausea487
Methaemoglobinaemia481
Fatigue477
Pyrexia468
Diarrhoea424
Rash398
Dyspnoea387

Age at onset

Neonate10
Infant17
Child28
Adolescent57
Adult1,101
Elderly446

Reporter sex

10,640 reports
Male · 45%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization3,830
Death934
Life-threatening655
Disabling210
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 933 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70771-1538-02 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP 2024-05-10 Active
70771-1538-03 1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP 2024-05-10 Active
70771-1538-08 1 BOTTLE, PUMP in 1 CARTON (70771-1538-8) / 90 g in 1 BOTTLE, PUMP 2024-05-10 Active

Pack size FAQ

What quantity is in NDC 70771-1538-02?
NDC 70771-1538-02 is listed by the FDA — 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump.
What NDC number is used to bill for this package of Dapsone 75 mg/g Gel?
Bill NDC 70771-1538-02 — the 11-digit billing format is 70771153802. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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 FDA registers it as 70771-1538-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70771-1538-02, written without dashes as 70771153802. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70771-1538-02, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1538) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. 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 2 other package presentations of this same product, including 1 bottle (70771-1538-03), 1 bottle (70771-1538-08). 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?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 9 words ▾

No readable label sections were found for this product.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70771-1531-06 · Zydus 70771-1539-00 · Zydus →
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.