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in the FDA label

Esomeprazole magnesium 40 mg Capsule, Delayed Release, 90-count

by Aphena Pharma Solutions - Tennessee, LLC · 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-60)
NDC 71610-0665-60
🏷️ FDA NDC (as labeled) 71610-665-60 billing pads the product segment with a zero
This package
Contains90-count Pack sizes4 compare ↓
Also comes in: 30 capsules 71610-0665-30 60 capsules 71610-0665-53 180 capsules 71610-0665-80
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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 Esomeprazole Magnesium (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 13, 2025 — Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0443-2025
Class II · May 13, 2025 — Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0442-2025
Class III · Nov 14, 2024 — Labeling: Not Elsewhere Classified - Wrong NDC number (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0102-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Oct 2022. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71610-665-60
Product NDC 71610-665
11-digit billing NDC 71610066560
NCPDP billing unit EA — each (per item)
Application # ANDA209735
Mechanism of action Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Oct 2022)
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance ESOMEPRAZOLE MAGNESIUM
GCN Seq No 047526
GCN 12868
HICL code 021607
Ingredient (HICL) Esomeprazole Magnesium
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 ESOMEPRAZOLE MAG DR 40 MG CAP
FDB brand name Esomeprazole Magnesium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71610-665-60 — 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 → 71610-0665-60. 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.

🏭 Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA209735 (ANDA)
Labeler code71610
Product typeHuman Prescription Drug
Portfolio795 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 ESOMEPRAZOLE MAG DR 40 MG CAP Ingredient Esomeprazole Magnesium
📖 What it is MedlinePlus · NLM

Prescription esomeprazole 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 esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the cha...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's blocking the 'acid pump' — a tiny enzyme in your stomach lining that releases acid. By shutting down that pump, esomeprazole cuts the amount of acid your stomach produces, giv...
  • What is esomeprazole actually doing in my body?
  • Before eating is best — ideally at least 30 minutes before your first meal of the day. Food can reduce how much of the medicine your body absorbs by nearly half, so timing really d...
  • Should I take it before or after eating?
📖 Read our full Esomeprazole guide →
9
Nutrient depletion considerations

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

🧪 Full Esomeprazole Magnesium 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 · 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: 30 capsules 60 capsules 180 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
Esomeprazole Magnesium 40 mg 00378-2351-77 Mylan 90 capsules $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 00904-6581-68 Major 1 capsule $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 16714-0980-01 NorthStar 30 capsules $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 31722-0665-10 Camber 1000 capsules $0.118 AB Availability likely —
Esomeprazole magnesium 40 mg 43547-0002-03 Solco 30 capsules $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 43598-0510-10 Dr. 1000 capsules $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 50268-0272-13 AvPAK 1 capsule $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 62175-0840-32 Lannett 30 capsules $0.118 AB Availability likely —
Esomeprazole magnesium 40 mg 63304-0735-10 Sun 1000 capsules $0.118 AB Availability likely —
Esomeprazole magnesium 40 mg 64980-0633-03 Rising 30 capsules $0.118 AB Availability likely —
esomeprazole magnesium 40 mg 68382-0442-06 Zydus 30 capsules $0.118 AB Availability likely —
Esomeprazole magnesium 40 mg 70010-0134-03 Granules 30 capsules $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 70069-0815-10 Somerset 1000 capsules $0.118 AB Availability likely —
esomeprazole magnesium 40 mg 70377-0056-11 Biocon 30 capsules $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 82009-0034-10 Quallent 1000 capsules $0.118 AB Availability likely —
Esomeprazole Magnesium 40 mg 68462-0391-10 Glenmark 1000 capsules $0.149 — FDA listed —
Nexium 40 mg 00186-5040-05 AstraZeneca 5 capsules — AB Discontinued —
Esomeprazole Magnesium 40 mg 00615-8628-39 NCS 30 capsules — AB FDA listed —
esomeprazole 40 mg 33342-0307-07 Macleods 30 capsules — — FDA listed —
Esomeprazole Magnesium 40 mg 50090-5134-00 A-S 30 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 50090-6128-01 A-S 90 capsules — — FDA listed —
Esomeprazole Magnesium 40 mg 50090-6943-00 A-S 90 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 50090-7360-01 A-S 90 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 50090-7896-00 A-S 90 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 50090-7949-00 A-S 90 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 50090-7950-01 A-S 90 capsules — AB FDA listed —
Esomeprazole magnesium 40 mg 51407-0743-10 Golden 1000 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 59651-0562-25 Aurobindo 25000 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 65862-0784-01 Aurobindo 100 capsules — AB FDA listed —
Esomeprazole magnesium 40 mg 67877-0479-05 Ascend 500 capsules — AB FDA listed —
Esomeprazole magnesium 40 mg 67877-0572-05 Ascend 500 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 68071-3934-09 NuCare 90 capsules — AB FDA listed —
esomeprazole magnesium 40 mg 68788-8524-01 Preferred 100 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 68788-8812-01 Preferred 100 capsules — AB FDA listed —
Esomeprazole magnesium 40 mg 69434-0013-01 Zhejiang 30 capsules — AB FDA listed —
esomeprazole magnesium 40 mg 70518-3850-00 REMEDYREPACK 30 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 70518-4581-00 REMEDYREPACK 30 capsules — AB FDA listed —
esomeprazole magnesium 40 mg 70771-1494-00 Zydus 1000 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 71205-0143-30 Proficient 30 capsules — AB FDA listed —
esomeprazole magnesium 40 mg 71335-1335-01 Bryant 90 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 71335-2040-01 Bryant 90 capsules — AB FDA listed —
Esomeprazole magnesium 40 mg 71335-2449-01 Bryant 90 capsules — AB FDA listed —
esomeprazole magnesium 40 mg 71335-2476-01 Bryant 90 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 71335-3149-01 Bryant 90 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 72189-0318-30 Direct 30 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 72789-0391-90 PD-Rx 90 capsules — AB FDA listed —
Esomeprazole magnesium 40 mg 76420-0227-30 Asclemed 30 capsules — AB FDA listed —
Esomeprazole Magnesium 40 mg 76420-0905-00 Asclemed 1000 capsules — AB FDA listed —
Esomeprazole Magnesium DR 40 mg 80425-0331-01 Advanced 30 capsules — AB FDA listed —
Esomeprazole magnesium 40 mg 80425-0440-01 Advanced 30 capsules — AB FDA listed —
esomeprazole magnesium 40 mg 82804-0078-30 Proficient 30 capsules — AB FDA listed —
Esomeprazole magnesium 40 mgthis 71610-0665-60 Aphena 90 capsules — AB Discontinued —
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
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.

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

Medicare Part D (outpatient prescription) spending for Esomeprazole Magnesium — the program that covers self-administered drugs. 18 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 Esomeprazole Magnesium. 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
$26.52M
Claims incl. refills
740.1K
Beneficiaries
544.7K
Spend / beneficiary
$48.68
Spend / claim
$35.83
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71610-0665-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-30) 2022-10-05 Discontinued by firm
71610-0665-53 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-53) 2022-10-05 Discontinued by firm
71610-0665-60 You're viewing this 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-60) 2022-10-05 Discontinued by firm
71610-0665-80 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-80) 2022-10-05 Discontinued by firm

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0665-60?
NDC 71610-0665-60 is a 90-count package — 90 capsule, delayed release in 1 bottle.
What is the difference between NDC 71610-0665-60 and NDC 71610-0665-30?
Both are Esomeprazole magnesium 40 mg Capsule, Delayed Release — the drug itself is identical. NDC 71610-0665-60 is the 90-count package, while NDC 71610-0665-30 is the 30 capsules package.
What NDC number is used to bill for this package of Esomeprazole magnesium 40 mg Capsule, Delayed Release?
Bill NDC 71610-0665-60 — the 11-digit billing format is 71610066560. 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 No longer marketed (per FDA listing data)
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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 71610-665-60, 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: 71610-0665-60, written without dashes as 71610066560. 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 71610-0665-60, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0665) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 capsules (71610-0665-30), 60 capsules (71610-0665-53), 180 capsules (71610-0665-80). 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?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 71610-0664-60 · Aphena 71610-0666-60 · Aphena →
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.