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Lansoprazole 15 mg Capsule, Delayed Release — NDC 43598-0109-27 package photo

Lansoprazole 15 mg Capsule, Delayed Release

by Dr. Reddy's Laboratories Inc. · 2 BOTTLE in 1 CARTON (43598-109-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
NDC 43598-0109-27
🏷️ FDA NDC (as labeled) 43598-109-27 billing pads the product segment with a zero
This package
Contains14 capsule, delayed release in 1 bottle Pack sizes5 compare ↓
Also priced by: Part D plans $0.4438/unit — full pricing hub ↓
Also comes in: 14 capsules 43598-0109-33 14 capsules 43598-0109-52 4000 capsules 43598-0109-48 4000 capsules 43598-0109-94
OTC Generic On market Non-controlled
🗂️ Data synced Aug 6, 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

🆔 Identity & classification

FDA NDC (as labeled) 43598-109-27
Product NDC 43598-109
11-digit billing NDC 43598010927
NCPDP billing unit EA — each (per item)
RxCUI 596843
UNII 0K5C5T2QPG
Application # ANDA202194
SPL Set ID 4a701c0d-fef5-aa12-01e6-e3680a161a7d
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
Physiologic effect Inhibition Gastric Acid Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-12
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance LANSOPRAZOLE
GCN Seq No 030106
GCN 01697
HICL code 008993
Ingredient (HICL) Lansoprazole
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4J
Therapeutic class — specific (HIC3) Proton-Pump Inhibitors
AHFS code 56:28.36.00
AHFS class Proton-Pump Inhibitors
FDB label name LANSOPRAZOLE DR 15 MG CAPSULE
FDB brand name Lansoprazole
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 43598-109-27 — 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 → 43598-0109-27. 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 Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors
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

LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA202194 (ANDA)
Labeler code43598
First marketedApr 2022
Product typeHuman Otc Drug
Portfolio158 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

Label name LANSOPRAZOLE DR 15 MG CAPSULE Ingredient Lansoprazole
📖 What it is MedlinePlus · NLM

Prescription lansoprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription lansoprazole is used to treat the damage from GERD in adults and children 1 year of age and older. Prescription lansoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription lansoprazole is also used to treat ulcers...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It does a lot more than heartburn relief. Lansoprazole is used to heal ulcers in the stomach and small intestine, treat acid reflux disease (GERD), repair acid damage to the esopha...
  • What exactly is lansoprazole treating — is it just for heartburn?
  • Timing actually matters quite a bit with lansoprazole. It works best when taken before a meal — ideally about 30 minutes before you eat. If you take it after food, your body absorb...
  • Does it matter when I take it — can I just take it whenever it's convenient?
📖 Read our full Lansoprazole guide →
9
Nutrient depletion considerations

Lansoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Lansoprazole 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.

💊 What it looks like

Color Blue / Pink
ShapeCapsule
ImprintRDY;398
Size3 mm
ScoringNot scored
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.

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

  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • UNII 0E53J927NA
    Magnesium carbonate is a mineral powder used in medicines as a filler to add bulk and as a buffer to help regulate acidity in the formulation.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

17 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesD&C Red 28, FD&C Blue No.1, FD&C Green 3, FD&C Red 40, gelatin, hydroxypropyl cellulose, iron oxide black, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 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 $0.4438 $12.43 / 28 capsules
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
Lansoprazole 15 mg 00093-7350-56 Teva 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 00378-8015-93 Mylan 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 60687-0111-21 American 1 capsule $0.147 AB Availability likely —
Lansoprazole 15 mg 67877-0274-30 Ascend 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 68001-0111-04 BluePoint 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 70756-0806-30 Lifestar 30 capsules $0.147 AB Availability likely —
Good Sense Lansoprazole 15 mg 00113-1114-01 L. 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 00536-1368-13 Rugby 14 capsules $0.428 — Availability likely —
lansoprazole 15 mg 45802-0878-01 Padagis 14 capsules $0.428 — Availability likely —
good neighbor pharmacy lansoprazole 15 mg 46122-0698-04 Amerisource 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 46122-0744-04 AMERISOURCEBERGEN 14 capsules $0.428 — Availability likely —
foster and thrive acid reducer 15 mg 70677-1103-01 Strategic 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 83324-0001-14 Chain 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 70000-0612-01 LEADER/ 14 capsules $0.432 — Availability likely —
Prevacid 24 HR 15 mg 00113-6117-01 L. 14 capsules — — FDA listed —
Lansoprazole 15 mg 00363-0037-14 Walgreens 14 capsules — — FDA listed —
lansoprazole 15 mg 00363-1212-01 Walgreen 14 capsules — — FDA listed —
up and up lansoprazole 15 mg 11673-0280-01 Target 14 capsules — — FDA listed —
Lansoprazole 15 mg 11673-0324-42 Target 14 capsules — — Discontinued —
Lansoprazole 15 mg 11822-0019-01 Rite 14 capsules — — Discontinued —
Lansoprazole 15 mg 11822-3374-05 Rite 14 capsules — — FDA listed —
Lansoprazole 15 mg 21130-0046-14 Albertsons 14 capsules — — Discontinued —
signature care acid reducer 15 mg 21130-0181-01 Safeway 14 capsules — — Discontinued —
Lansoprazole 15 mg 27241-0019-03 Ajanta 30 capsules — — FDA listed —
Lansoprazole 15 mg 30142-0983-14 Kroger 14 capsules — — Discontinued —
Lansoprazole 15 mg 31722-0570-01 Camber 100 capsules — AB FDA listed —
Lansoprazole 15 mg 33342-0310-07 Macleods 30 capsules — — FDA listed —
topcare lansoprazole 15 mg 36800-0392-01 Topco 14 capsules — — FDA listed —
Lansoprazole 15 mg 37808-0934-14 H 14 capsules — — Discontinued —
equaline lansoprazole 15 mg 41163-0150-01 United 14 capsules — — FDA listed —
lansoprazole 15 mg 41250-0391-01 Meijer 14 capsules — — FDA listed —
Lansoprazole 15 mgthis 43598-0109-27 Dr. 14 capsules — — FDA listed —
Lansoprazole 15 mg 43598-0161-33 Dr. 14 capsules — — FDA listed —
equate lansoprazole delayed release 15 mg 49035-0411-01 Wal-Mart 14 capsules — — FDA listed —
Lansoprazole 15 mg 50090-6079-00 A-S 30 capsules — AB FDA listed —
Lansoprazole 15 mg 51316-0006-14 CVS 14 capsules — — Discontinued —
Lansoprazole 15 mg 55111-0398-01 Dr.Reddy's 100 capsules — AB FDA listed —
Lansoprazole 15 mg 55111-0739-27 Dr. 14 capsules — — FDA listed —
dg health lansoprazole 15 mg 55910-0307-01 Dolgencorp 14 capsules — — FDA listed —
lansoprazole 15 mg 56062-0117-01 Publix 14 capsules — — FDA listed —
lansoprazole 15 mg 56062-0283-01 Publix 14 capsules — — FDA listed —
Kirkland Signature Lansoprazole 15 mg 63981-0582-03 Costco 14 capsules — — FDA listed —
Lansoprazole 15 mg 68071-2274-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3633-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3634-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3687-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-4456-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 68196-0045-03 Sam's 14 capsules — — Discontinued —
Members Mark Lansoprazole 15 mg 68196-0279-03 Sam's 14 capsules — — FDA listed —
Berkley And Jensen Lansoprazole 15 mg 68391-0823-03 BJWC 14 capsules — — FDA listed —
Lansoprazole 15 mg 68788-6390-01 Preferred 100 capsules — AB FDA listed —
Lansoprazole 15 mg 69842-0755-14 CVS 14 capsules — — FDA listed —
Lansoprazole 15 mg 70700-0262-30 Xiromed 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-0058-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-2957-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-9680-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-9693-01 Bryant 30 capsules — AB FDA listed —
lansoprazole 15 mg 71335-9695-01 Bryant 30 capsules — — FDA listed —
basic care lansoprazole 15 mg 72288-0301-01 Amazon.com 14 capsules — — FDA listed —
basic care lansoprazole 15 mg 72288-0343-01 Amazon.com 14 capsules — — FDA listed —
careone acid reducer 15 mg 72476-0020-01 Retail 14 capsules — — Discontinued —
equate lansoprazole 15 mg 79903-0068-01 WALMART 14 capsules — — FDA listed —
Lansoprazole DR 15 mg 80425-0148-01 Advanced 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-2734-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 72288-0827-03 Amazon.com 14 capsules — — 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

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 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 Lansoprazole — the program that covers self-administered drugs. 13 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 Lansoprazole. 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
$11.11M
Claims incl. refills
326.1K
Beneficiaries
241.2K
Spend / beneficiary
$46.07
Spend / claim
$34.08
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 Lansoprazole — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease32,791
Acute Kidney Injury18,792
Renal Failure13,844
End Stage Renal Disease9,798
Renal Injury9,520
Nausea9,253
Diarrhoea9,101

Age at onset

Neonate44
Infant117
Child500
Adolescent444
Adult9,550
Elderly9,907

Reporter sex

177,063 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization64,594
Life-threatening12,268
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25,105 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 Per unit Per pack Marketing startStatus
43598-0109-27 You're viewing this 2 BOTTLE in 1 CARTON (43598-109-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE — — 2022-04-12 Active
43598-0109-33 3 BOTTLE in 1 CARTON (43598-109-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.4184 / ea $17.57 2022-04-12 Active
43598-0109-52 1 BOTTLE in 1 CARTON (43598-109-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE — — 2022-04-12 Active
43598-0109-48 12 POUCH in 1 CASE (43598-109-48) / 4000 CAPSULE, DELAYED RELEASE in 1 POUCH — — — Active
43598-0109-94 4000 CAPSULE, DELAYED RELEASE in 1 POUCH (43598-109-94) — — — Active

Pack size FAQ

What quantity is in NDC 43598-0109-27?
NDC 43598-0109-27 is listed by the FDA — 2 bottle in 1 carton / 14 capsule, delayed release in 1 bottle.
What NDC number is used to bill for this package of Lansoprazole 15 mg Capsule, Delayed Release?
Bill NDC 43598-0109-27 — the 11-digit billing format is 43598010927. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) 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 — 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

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 43598-109-27, 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: 43598-0109-27, written without dashes as 43598010927. 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 43598-0109-27, the first segment (43598) is the labeler code FDA assigned to Dr. Reddy's Laboratories Inc.; the middle segment (0109) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (27) 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 Dr. Reddy's Laboratories 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 4 other package presentations of this same product, including 14 capsules (43598-0109-33), 14 capsules (43598-0109-52), 4000 capsules (43598-0109-48). 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?
Dr. Reddy's Laboratories 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

⏱️ Dosage and Administration 155 words ▾

Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use.

Heartburn in children may sometimes be caused by a serious condition.

⚠️ Warnings ~1 min read ▾

Warnings Allergy alert: do not use if you are allergic to lansoprazole lansoprazole may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain These may be signs of a serious condition.

See your doctor Ask a doctor before use if you have liver disease had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) .

🧪 Active Ingredient 9 words ▾

Active ingredient (in each capsule) Lansoprazole USP, 15 mg

🧪 Inactive Ingredients 45 words ▾

Inactive ingredients D&C Red 28, FD&C Blue No.1, FD&C Green 3, FD&C Red 40, gelatin, hydroxypropyl cellulose, iron oxide black, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

🎯 Purpose 3 words ▾

Purpose Acid Reducer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43598-0108-37 · Dr. 43598-0110-01 · Dr. →
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.