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Esomeprazole Magnesium 20 mg Capsule, Delayed Release, 60-count — NDC 60760-0877-60 package photo

Esomeprazole Magnesium 20 mg Capsule, Delayed Release, 60-count

by St. Mary's Medical Park Pharmacy · 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-877-60)
NDC 60760-0877-60
🏷️ FDA NDC (as labeled) 60760-877-60 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 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 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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 60760-877-60
Product NDC 60760-877
11-digit billing NDC 60760087760
Application # ANDA211977
SPL Set ID 5baf88c3-eda4-8aa6-e063-6294a90a68b4
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-17
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance ESOMEPRAZOLE MAGNESIUM
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 60760-877-60 — 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 → 60760-0877-60. 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

LabelerSt. Mary's Medical Park Pharmacy
Application holderHETERO LABS LTD UNIT III
FDA applicationANDA211977 (ANDA)
Labeler code60760
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio269 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It'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.

💊 What it looks like

Color white
ShapeCapsule
ImprintH;E2
Size14 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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 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 R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • 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 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 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 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 MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • 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.
  • 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 · 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.
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 20 mg 16714-0979-01 NorthStar 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 43598-0509-10 Dr. 1000 capsules $0.145 AB Availability likely —
Esomeprazole magnesium 20 mg 64980-0632-03 Rising 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 70069-0814-10 Somerset 1000 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 62175-0820-32 Lannett 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 00378-2350-77 Mylan 90 capsules $0.145 AB Availability likely —
esomeprazole magnesium 20 mg 70377-0055-11 Biocon 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 31722-0664-10 Camber 1000 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 82009-0033-10 Quallent 1000 capsules $0.145 AB Availability likely —
Esomeprazole magnesium 20 mg 63304-0734-10 Sun 1000 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 68462-0390-10 Glenmark 1000 capsules $0.177 — FDA listed —
Esomeprazole 20 mg 51660-0027-14 Ohm 14 capsules $0.343 — FDA listed —
Esomeprazole Magnesium 20 mg 16571-0880-41 Rising 14 capsules $0.346 — Availability likely —
Esomeprazole Magnesium 20 mg 69230-0320-31 Camber 14 capsules $0.346 — Availability likely —
Esomeprazole Magnesium 20 mg 43598-0407-27 Dr. 14 capsules $0.349 — Availability likely —
Esomeprazole Magnesium 20 mg 63868-0425-14 CHAIN 14 capsules $0.361 — FDA listed —
Esomeprazole magnesium 20 mg 21130-0718-41 BETTER 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 49483-0718-41 TIME 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 50090-6213-00 A-S 30 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 63187-0964-30 Proficient 30 capsules — AB FDA listed —
Esomeprazole 20 mg 63941-0999-14 VALU 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 69618-0073-42 Reliable 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 72657-0124-42 GLENMARK 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 72559-0011-06 LITTLE 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 37808-0115-14 HEB 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 68071-3419-06 NuCare 60 capsules — AB FDA listed —
Esomeprazole magnesium 20 mg 70010-0133-03 Granules 30 capsules — AB FDA listed —
Nexium 24HR 20 mg 50090-1492-00 A-S 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 00363-3298-01 Walgreens 14 capsules — — FDA listed —
Esomeprazole Magnesium Delayed Release 20 mg 00363-7810-41 WALGREENS 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 79903-0382-42 Walmart 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 83324-0200-14 CHAIN 14 capsules — — FDA listed —
24 HOUR Esomeprazole Magnesium 20 mg 85828-0718-45 Grocery 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 30142-0261-14 The 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 43598-0067-42 Dr. 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 45865-0163-30 Medsource 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 50090-6198-00 A-S 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 43598-0926-28 Dr. 14 capsules — — FDA listed —
Esomeprazole 20 mg 73581-0013-42 YYBA 14 capsules — — FDA listed —
Nexium 24HR ClearMinis 20 mg 00573-2452-02 Haleon 2 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 37808-0364-14 H 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 43598-0327-27 Dr. 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 69434-0012-01 Zhejiang 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 71335-1170-01 Bryant 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 80425-0419-01 Advanced 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 80425-0420-01 Advanced 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 53943-0527-14 Discount 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 68071-3735-03 NuCare 30 capsules — AB FDA listed —
Esomeprazole 20 mg 51316-0715-14 CVS 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 00363-0772-14 WALGREENS 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 76420-0904-00 Asclemed 1000 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 21130-0257-41 BETTER 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 43598-0812-14 Dr. 14 capsules — — Discontinued —
Esomeprazole magnesium 20 mg 51407-0742-10 Golden 1000 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 53041-0666-07 Guardian 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 53943-0039-14 DISCOUNT 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 58602-0707-05 Aurohealth 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 67877-0478-05 Ascend 500 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 71335-2505-01 Bryant 30 capsules — AB FDA listed —
esomeprazole magnesium 20 mg 71335-9713-01 Bryant 30 capsules — AB FDA listed —
Nexium 24HR 20 mg 00573-2450-02 Haleon 2 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 30142-0528-14 KROGER 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 71335-2018-01 Bryant 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 64980-0664-19 Rising 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 69844-0115-01 Graviti 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 37808-0646-41 H-E-B 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 50090-7990-00 A-S 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 60687-0934-21 American 1 capsule — AB FDA listed —
Esomeprazole 20 mg 57896-0740-42 GERI-CARE 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mgthis 60760-0877-60 St. 60 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

🏛️
2026
On the market since
Sep 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.

📊 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
60760-0877-60 You're viewing this 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-877-60) 2026-09-17 Active

🧭 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 60760-877-60, 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: 60760-0877-60, written without dashes as 60760087760. 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 60760-0877-60, the first segment (60760) is the labeler code FDA assigned to St. Mary's Medical Park Pharmacy; the middle segment (0877) 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.
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 St. Mary's Medical Park Pharmacy. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
St. Mary's Medical Park Pharmacy 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. Prefer the government’s original formatting? View this label on DailyMed ↗
← 60760-0875-28 · St. 60760-0878-10 · St. →
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.