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Omeprazole 40 mg Capsule, Delayed Release, 1,000-count — NDC 65841-0761-10 package photo

Omeprazole 40 mg Capsule, Delayed Release, 1,000-count

by Zydus Lifesciences Limited · 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-761-10)
NDC 65841-0761-10
🏷️ FDA NDC (as labeled) 65841-761-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.2027/unit — full pricing hub ↓
Also comes in: 30 capsules 65841-0761-06 90 capsules 65841-0761-16 100 capsules 65841-0761-01 500 capsules 65841-0761-05
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 Omeprazole (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 30, 2025 — Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0525-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 65841-761-10
Product NDC 65841-761
11-digit billing NDC 65841076110
RxCUI 198051, 199119, 200329
UNII KG60484QX9
Application # ANDA091352
SPL Set ID 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors; Cytochrome P450 2C19 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-11-23
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance OMEPRAZOLE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 65841-761-10 — 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 → 65841-0761-10. 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, Cytochrome P450 2C19 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

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA091352 (ANDA)
Labeler code65841
First marketedNov 2012
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
  • Omeprazole turns down your stomach's acid production by blocking the pump that makes acid in the first place. Depending on why you're taking it, that can mean relief from heartburn...
  • What exactly is omeprazole supposed to do for me?
  • Take it about 30 minutes before a meal, ideally before breakfast. Taking it before eating gives it the best chance to be absorbed and ready to work when your stomach starts produci...
  • When should I take it — before or after eating?
📖 Read our full Omeprazole guide →
9
Nutrient depletion considerations

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

🧪 Full Omeprazole 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 Purple / White / Brown
ShapeCapsule
ImprintZA;11;40mg
Size19 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 1364PS73AF
    Acetone is a clear, volatile liquid solvent. In medications, it helps dissolve or extract active ingredients during manufacturing and may be used in certain liquid formulations or coating processes.
  • 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 PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • 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 RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 8LDD2V82F5
    A plant-derived polymer that forms a protective coating around tablets or capsules. It delays release of the medication until it reaches the small intestine, protecting sensitive ingredients and improving how the body absorbs them.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • 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.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

19 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 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 $0.2027 $202.70 / 1000 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
Omeprazole 40 mg 16714-0123-01 NorthStar 30 capsules $0.049 AB Availability likely —
Omeprazole 40 mg 50268-0657-15 AvPAK 1 capsule $0.049 AB Availability likely —
Omeprazole 40 mg 55111-0159-01 Dr. 100 capsules $0.049 AB Availability likely —
Omeprazole 40 mg 55111-0645-01 Dr. 100 capsules $0.049 AB Availability likely —
Omeprazole 40 mg 60505-0146-00 Apotex 30 capsules $0.049 AB Discontinued —
Omeprazole 40 mg 60687-0608-01 American 1 capsule $0.049 AB Availability likely —
Omeprazole 40 mg 68382-0500-01 Zydus 100 capsules $0.049 AB Availability likely —
Omeprazole 40 mg 68462-0397-01 Glenmark 100 capsules $0.049 AB Availability likely —
Omeprazole 40 mg 82009-0023-05 Quallent 500 capsules $0.049 AB Availability likely —
Omeprazole 40 mg 00781-2234-01 Sandoz 100 capsules $0.051 AB Availability likely —
Omeprazole 40 mg 62175-0136-32 Lannett 30 capsules $0.053 AB FDA listed —
Omeprazole 40 mg 00615-8079-05 NCS 15 capsules — AB FDA listed —
Omeprazole 40 mg 42708-0159-14 QPharma, 14 capsules — AB FDA listed —
Omeprazole 40 mg 43353-0829-60 Aphena 90 capsules — AB FDA listed —
Omeprazole 40 mg 50090-2769-00 A-S 30 capsules — AB FDA listed —
Omeprazole 40 mg 50090-5501-00 A-S 90 capsules — AB FDA listed —
Omeprazole 40 mg 50090-6720-00 A-S 30 capsules — AB FDA listed —
Omeprazole 40 mg 50090-6721-00 A-S 90 capsules — AB FDA listed —
Omeprazole 40 mg 50090-7366-00 A-S 30 capsules — AB FDA listed —
Omeprazole 40 mg 50090-7367-00 A-S 90 capsules — AB FDA listed —
Omeprazole 40 mg 51407-0664-00 Golden 50000 capsules — AB Discontinued —
Omeprazole 40 mg 51407-0814-01 Golden 100 capsules — AB FDA listed —
Omeprazole 40 mg 51407-0943-00 Golden 1 capsule — AB FDA listed —
Omeprazole 40 mg 51655-0452-25 Northwind 60 capsules — AB FDA listed —
Omeprazole 40 mg 57237-0162-01 Rising 100 capsules — AB FDA listed —
Omeprazole 40 mg 59651-0003-01 Aurobindo 100 capsules — — FDA listed —
Omeprazole 40 mg 60760-0841-30 ST. 30 capsules — AB FDA listed —
Omeprazole 40 mg 63187-0170-30 Proficient 30 capsules — AB FDA listed —
Omeprazole 40 mg 63187-0828-14 Proficient 14 capsules — AB FDA listed —
Omeprazole 40 mgthis 65841-0761-10 Zydus 1000 capsules — AB FDA listed —
Omeprazole 40 mg 68071-2199-04 NuCarePharmaceuticals, 14 capsules — AB FDA listed —
Omeprazole 40 mg 68071-2741-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 40 mg 68071-4906-09 NuCare 90 capsules — AB FDA listed —
Omeprazole 40 mg 68788-6995-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 40 mg 68788-8771-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 40 mg 70518-0199-00 REMEDYREPACK 90 capsules — AB FDA listed —
Omeprazole 40 mg 70700-0151-00 Xiromed, 1 capsule — AB FDA listed —
Omeprazole 40 mg 71205-0157-30 Proficient 30 capsules — AB FDA listed —
Omeprazole 40 mg 71335-0299-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71335-1395-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71335-1532-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71335-1851-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71335-9744-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0248-60 Aphena 90 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0280-60 Aphena 90 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0688-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0875-53 Aphena 60 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0876-53 Aphena 60 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0880-00 Aphena 1000 capsules — AB FDA listed —
Omeprazole 40 mg 72162-2388-00 Bryant 1000 capsules — AB FDA listed —
Omeprazole 40 mg 72789-0155-90 PD-Rx 90 capsules — AB FDA listed —
Omeprazole 40 mg 72789-0257-90 PD-Rx 90 capsules — AB FDA listed —
Omeprazole 40 mg 76420-0879-00 Asclemed 1000 capsules — AB FDA listed —
Omeprazole DR 40 mg 80425-0109-01 Advanced 30 capsules — AB FDA listed —
Omeprazole DR 40 mg 80425-0169-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 40 mg 82868-0080-60 Northwind 60 capsules — AB FDA listed —
Omeprazole 40 mg 85534-0037-00 HAWAII 30 capsules — 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

🏛️
2012
On the market since
Nov 2012
📍
2026
Currently FDA-listed
14 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 Omeprazole — 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 Omeprazole. 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
$75.01M
Claims incl. refills
7.1M
Beneficiaries
5.3M
Spend / beneficiary
$14.18
Spend / claim
$10.59
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 Omeprazole — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease36,807
Nausea27,095
Fatigue26,259
Diarrhoea25,668
Acute Kidney Injury23,964
Dyspnoea21,145
Pain20,498

Age at onset

Neonate292
Infant271
Child706
Adolescent877
Adult32,838
Elderly30,558

Reporter sex

448,293 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization150,621
Death39,276
Life-threatening19,121
Disabling14,768
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 45,465 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
65841-0761-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-761-01) 2012-11-23 Active
65841-0761-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-761-05) 2012-11-23 Active
65841-0761-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-761-06) 2012-11-23 Active
65841-0761-10 You're viewing this 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-761-10) 2012-11-23 Active
65841-0761-16 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-761-16) 2012-11-23 Active

You're viewing the largest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65841-0761-10?
NDC 65841-0761-10 is a 1,000-count package — 1000 capsule, delayed release in 1 bottle.
What is the difference between NDC 65841-0761-10 and NDC 65841-0761-06?
Both are Omeprazole 40 mg Capsule, Delayed Release — the drug itself is identical. NDC 65841-0761-10 is the 1,000-count package, while NDC 65841-0761-06 is the 30 capsules package.
What NDC number is used to bill for this package of Omeprazole 40 mg Capsule, Delayed Release?
Bill NDC 65841-0761-10 — the 11-digit billing format is 65841076110. 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 65841-761-10, 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: 65841-0761-10, written without dashes as 65841076110. 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 65841-0761-10, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0761) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 4 other package presentations of this same product, including 30 capsules (65841-0761-06), 90 capsules (65841-0761-16), 100 capsules (65841-0761-01). 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.

📄 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.
💬 Medication Guide
💬 Medication Guide 2 words ▾

SPL MEDGUIDE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65841-0760-01 · Zydus 65841-0762-01 · 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.