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Amlodipine Besylate 10 mg Tablet, 100-count — NDC 65841-0622-77 package photo

Amlodipine Besylate 10 mg Tablet, 100-count

by Zydus Lifesciences Limited · 10 BLISTER PACK in 1 CARTON (65841-622-77) / 10 TABLET in 1 BLISTER PACK
NDC 65841-0622-77
🏷️ FDA NDC (as labeled) 65841-622-77 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.0799/unit — full pricing hub ↓
Also comes in: 90 tablets 65841-0622-16 100 tablets 65841-0622-01 500 tablets 65841-0622-05
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

🆔 Identity & classification

FDA NDC (as labeled) 65841-622-77
Product NDC 65841-622
11-digit billing NDC 65841062277
RxCUI 197361, 308135, 308136
UNII 864V2Q084H
Application # ANDA078226
SPL Set ID cacb3551-c579-41cb-bed6-4b4d8b0644fc
Established class (EPC) Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker
Mechanism of action Calcium Channel Antagonists; Cytochrome P450 3A Inhibitors
Chemical class Dihydropyridines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-09-21
Route ORAL
Dosage form TABLET
Substance AMLODIPINE BESYLATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 65841-622-77 — 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 → 65841-0622-77. 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 Dihydropyridine Calcium Channel Blocker class.

Pharmacologic class Dihydropyridine Calcium Channel Blocker, Calcium Channel Blocker
Drug family (ATC) Renin-inhibitors, ACE inhibitors and calcium channel blockers, Dihydropyridine derivatives
How it works Calcium Channel Antagonists, Cytochrome P450 3A 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 applicationANDA078226 (ANDA)
Labeler code65841
First marketedSep 2007
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
  • Amlodipine is used mainly to treat two things: high blood pressure and certain types of chest pain (angina). For high blood pressure, it's approved for adults and children as young...
  • The most common one is swelling in your ankles or legs — this is dose-related, so it's more noticeable at higher doses, and women tend to notice it more than men. Dizziness, flushi...
  • What side effects should I expect, and which ones should I call about?
  • You can take amlodipine with or without food — it doesn't make a meaningful difference in how well it's absorbed. Because it stays in your system for a long time (a half-life of 30...
📖 Read our full Amlodipine guide →
2
Nutrient depletion considerations

Amlodipine Besylate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Amlodipine Besylate 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
ShapeRound
ImprintZ;5
Size8 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

4 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 $0.0799 $7.99 / 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amlodipine Besylate 10 mg 00480-7168-98 Teva 90 tablets $0.015 AB Discontinued —
Amlodipine Besylate 10 mg 00904-6371-61 Major 100 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 29300-0398-05 Unichem 500 tablets $0.015 AB Availability likely —
amlodipine besylate 10 mg 59762-2135-01 Mylan 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 60687-0496-01 American 100 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 67877-0199-05 Ascend 500 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 67877-0902-10 Ascend 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 68180-0721-03 Lupin 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 68645-0516-54 Legacy 30 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 68645-0580-54 Legacy 30 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 69097-0128-05 Cipla 90 tablets $0.015 AB Availability likely —
AMLODIPINE BESYLATE 10 mg 69584-0023-09 Oxford 90 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 82009-0028-10 Quallent 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 42806-0057-05 Epic 500 tablets $0.017 AB FDA listed —
Amlodipine Besylate 10 mg 69097-0838-05 Cipla 90 tablets $0.019 AB FDA listed —
Norvasc 10 mg 00069-1540-41 PFIZER 100 tablets $11.190 AB Discontinued —
Norvasc 10 mg 58151-0355-77 Viatris 90 tablets $11.976 AB Availability likely —
Amlodipine Besylate 10 mg 00615-8431-05 NCS 15 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 42291-0027-10 AvKARE 1000 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 43063-0041-30 PD-Rx 30 tablets — AB FDA listed —
Amlodipine besylate 10 mg 43353-0989-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 43489-0101-01 China 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 48433-0157-20 Safecor 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-2581-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-5354-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-5355-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-5550-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-6808-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-6809-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 51407-0951-10 GSMS, 1000 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 51655-0586-52 Northwind 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 51655-0869-52 Northwind 30 tablets — AB FDA listed —
amlodipine besylate 10 mg 52605-0043-10 POLYGEN 1000 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 55154-6875-00 Cardinal 10 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 60760-0445-30 ST. 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 63187-0914-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mgthis 65841-0622-77 Zydus 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 65862-0103-05 Aurobindo 500 tablets — — FDA listed —
Amlodipine Besylate 10 mg 68071-2305-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68071-2520-09 NuCare 90 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 68071-3453-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68071-3698-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68382-0123-01 Zydus 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68788-4085-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68788-7985-01 Preferred 100 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 68788-8451-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68788-8543-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 70518-0297-00 REMEDYREPACK 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 70518-2632-00 REMEDYREPACK 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 70518-4464-00 REMEDYREPACK 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71205-0488-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71205-0506-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71335-0218-01 Bryant 30 tablets — AB FDA listed —
Amlodipine besylate 10 mg 71335-0843-01 Bryant 30 tablets — AB Discontinued —
Amlodipine Besylate 10 mg 71335-0945-01 Bryant 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71335-1865-01 Bryant 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71335-1887-01 Bryant 30 tablets — — Discontinued —
Amlodipine Besylate 10 mg 71335-2507-00 Bryant 7 tablets — AB FDA listed —
amlodipine besylate 10 mg 71610-0469-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0620-30 Aphena 30 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 71610-0830-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0928-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0938-30 Aphena 30 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 71610-0978-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0988-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 72189-0529-90 Direct_Rx 90 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 72789-0262-90 PD-Rx 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 72789-0516-30 PD-Rx 30 tablets — AB FDA listed —
Amlodipine besylate 10 mg 76282-0239-05 Exelan 500 tablets — AB FDA listed —
Amlodipine besylate 10 mg 76282-0509-05 Exelan 500 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 82804-0164-90 Proficient 90 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 82804-0971-00 Proficient 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 82868-0031-90 Northwind 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 83209-0399-10 Boswell 10 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 87441-0016-01 Unit 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68071-1980-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 67296-2297-03 Redpharm 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 00615-8652-05 NCS 15 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 60687-0961-01 American 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 67046-1157-03 Coupler 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 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 Amlodipine Besylate — the program that covers self-administered drugs. 21 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 Amlodipine Besylate. 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
$85.77M
Claims incl. refills
12.9M
Beneficiaries
9.9M
Spend / beneficiary
$8.67
Spend / claim
$6.65
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 Amlodipine besylate — the ingredient across all brands.

Top reported reactions

Fatigue10,835
Nausea9,443
Diarrhoea8,945
Dyspnoea8,684
Dizziness7,742
Pain7,537
Headache7,386

Age at onset

Neonate35
Infant16
Child36
Adolescent76
Adult9,166
Elderly14,089

Reporter sex

168,900 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization61,348
Death15,098
Life-threatening7,111
Disabling4,816
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10,506 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
65841-0622-01 100 TABLET in 1 BOTTLE (65841-622-01) 2007-09-21 Active
65841-0622-05 500 TABLET in 1 BOTTLE (65841-622-05) 2007-09-21 Active
65841-0622-16 90 TABLET in 1 BOTTLE (65841-622-16) 2007-09-21 Active
65841-0622-77 You're viewing this 10 BLISTER PACK in 1 CARTON (65841-622-77) / 10 TABLET in 1 BLISTER PACK 2007-09-21 Active

Pack size FAQ

What quantity is in NDC 65841-0622-77?
NDC 65841-0622-77 is a 100-count package — 10 blister pack in 1 carton / 10 tablet in 1 blister pack.
What is the difference between NDC 65841-0622-77 and NDC 65841-0622-16?
Both are Amlodipine Besylate 10 mg Tablet — the drug itself is identical. NDC 65841-0622-77 is the 100-count package, while NDC 65841-0622-16 is the 90 tablets package.
What NDC number is used to bill for this package of Amlodipine Besylate 10 mg Tablet?
Bill NDC 65841-0622-77 — the 11-digit billing format is 65841062277. 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 65841-622-77, 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: 65841-0622-77, written without dashes as 65841062277. 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 65841-0622-77, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0622) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (77) 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 3 other package presentations of this same product, including 90 tablets (65841-0622-16), 100 tablets (65841-0622-01), 500 tablets (65841-0622-05). 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 ↗
← 65841-0621-01 · Zydus 65841-0626-01 · 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.