Home › NDC Lookup › Ingredients › Dapsone › 70771-1980-03
Dapsone 100 mg Tablet, 30-count — NDC 70771-1980-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dapsone 100 mg Tablet, 30-count — NDC 70771-1980-3 (Billing 70771-1980-03)

by Zydus Lifesciences Limited · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Dapsone 100 mg Tablet from Zydus Lifesciences Limited, marketed since Feb 2026 and currently FDA-listed.

NDC 70771-1980-03
🏷️ FDA NDC (as labeled) 70771-1980-3 billing pads the package segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.7885/unit — full pricing hub ↓
Product page 70771-1980-01 Also comes in: 100 tablets 70771-1980-1
Rx only Generic 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 70771-1980-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1980 product · 3 package
Package marketed since
Feb 27, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7077119803 0
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1980-3
Product NDC 70771-1980
11-digit billing NDC 70771198003
RxCUI 197557, 197558
UNII 8W5C518302
Application # ANDA220103
SPL Set ID 1d6bc112-ba2f-40ab-975d-9cfbc853cd11
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 2026-02-27
Route ORAL
Dosage form TABLET
Substance DAPSONE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 197557
Why two NDCs? The FDA registers this code as 70771-1980-3 — 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 → 70771-1980-03. 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.

Clinical

📖 What it is MedlinePlus · NLM

Dapsone is used to treat leprosy and skin infections. 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 depends on the form. Tablets treat dermatitis herpetiformis and leprosy. The gel treats acne vulgaris in people 9 and older. Make sure you know which one you were given.
  • Wash and gently pat your skin dry. Rub in a thin, pea-sized layer, and keep it out of your mouth, eyes and vagina. Aczone Gel 7.5% is once daily, while dapsone gel 5% is twice dail...
  • With the gel, mostly dryness, redness and some oiliness or peeling where you apply it. These are the common ones. They are usually not the reason to panic, but tell us if they both...
  • Call for help if your lips, mouth or nail beds turn bluish-gray, or if you notice signs of anemia. Also report sore throat, fever, pale skin, yellow skin or eyes, purple spots, sev...
📖 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.

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 eachPer 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 $0.7885 $23.66 / 30 tablets
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
70771-1980-01 70771-1980-1 Main listing 100 TABLET in 1 BOTTLE 2026-02-27 — Active
70771-1980-03 You're viewing this 30 TABLET in 1 BOTTLE 2026-02-27 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 70771-1980-01?
Both are Dapsone 100 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 70771-1980-01 is the 100 tablets package.
What NDC number is used to bill for this package of Dapsone 100 mg Tablet?
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
Dapsone 100 mg 64980-0566-01 Rising 100 tablets $0.806 AB Availability likely —
Dapsone 100 mg 69367-0379-01 Westminster 100 tablets $0.806 AB Availability likely —
Dapsone 100 mg 69367-0410-01 Westminster 100 tablets $0.806 AB Availability likely —
Dapsone 100 mg 70954-0136-10 ANI 30 tablets $0.806 AB Availability likely —
Dapsone 100 mg 72578-0178-01 Viona 100 tablets $0.806 AB Availability likely —
Dapsone 100 mg 13925-0505-01 Seton 100 tablets $0.942 AB Discontinued —
Dapsone 100 mg 51672-4198-02 Sun 30 tablets — — Discontinued —
Dapsone 100 mg 62135-0966-30 Chartwell 30 tablets — — FDA listed —
Dapsone 100 mg 67046-1477-03 Coupler 30 tablets — AB FDA listed —
Dapsone 100 mgthis 70771-1980-03 Zydus 30 tablets — AB FDA listed —
Dapsone 100 mg 82804-0989-00 Proficient 100 tablets — AB FDA listed —
Dapsone 100 mg 83098-0101-01 Everest 100 tablets — AB FDA listed —
Dapsone 100 mg 83209-0566-30 Boswell 30 tablets — AB FDA listed —
Dapsone 100mg 100 mg 85185-0105-01 Solis 30 tablets — AB FDA listed —
Dapsone 100 mg 33342-0535-07 Macleods 30 tablets — 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

What it looks like

Color White
ShapeRound
Imprint1714
Size1 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 Dapsone 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.

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

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

5 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.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS LIFESCIENCES LTD
FDA applicationANDA220103 (ANDA)
Labeler code70771
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 42 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1979-3 in bottle of 30 tablets Dapsone Tablets USP, 25 mg Rx only 30 tablets NDC 70771-1980-3 in bottle of 30 tablets Dapsone Tablets USP, 100 mg Rx only 30 tablets 25 mg label 100 mg 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 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.

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: 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 1 other package presentation of this same product, including 100 tablets (70771-1980-01). 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.
← 70771-1979-01 · Zydus 70771-1982-01 · 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.