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Duloxetine 60 mg Capsule, Delayed Release, 90-count — NDC 65841-0801-16 package photo

Duloxetine 60 mg Capsule, Delayed Release, 90-count

by Zydus Lifesciences Limited · 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-16)
NDC 65841-0801-16
🏷️ FDA NDC (as labeled) 65841-801-16 billing pads the product segment with a zero
This package
Contains90-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.3495/unit — full pricing hub ↓
Also comes in: 30 capsules 65841-0801-06 1000 capsules 65841-0801-10
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 Duloxetine (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 14, 2026 — CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. (Asclemed USA Inc.) · FDA recall D-0555-2026
Class II · Apr 29, 2026 — CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. (Ajanta Pharma Ltd.) · FDA recall D-0514-2026
Class II · Apr 29, 2026 — CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. (Ajanta Pharma Ltd.) · FDA recall D-0516-2026
Class II · Apr 29, 2026 — CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. (Ajanta Pharma Ltd.) · FDA recall D-0515-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 65841-801-16
Product NDC 65841-801
11-digit billing NDC 65841080116
RxCUI 596926, 596930, 596934
UNII 9044SC542W
UPC 0365841800166, 0365841801163, 0365841799163
Application # ANDA090739
SPL Set ID f36b414e-ace4-4f04-a80f-75bb25db430d
Established class (EPC) Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of action Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-05-27
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance DULOXETINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 65841-801-16 — 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 → 65841-0801-16. 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 Serotonin and Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Serotonin and Norepinephrine Reuptake Inhibitor
Drug family (ATC) Other antidepressants
How it works Norepinephrine Uptake Inhibitors, Serotonin Uptake 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 HEALTHCARE USA LLC
FDA applicationANDA090739 (ANDA)
Labeler code65841
First marketedMay 2014
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

📖 What it is MedlinePlus · NLM

Duloxetine is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life). Duloxetine is also used to pain associated with diabetic neuropathy (damage to nerves that can develop in people who have diabetes) and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). It is also used to treat ongoing bone or muscle pain. Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It work...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You're right to ask — duloxetine does a lot more than treat depression. It's also approved for generalized anxiety disorder, diabetic nerve pain, fibromyalgia, and chronic musculos...
  • What is duloxetine actually used for? My doctor prescribed it but I wasn't sure it was just for depression.
  • It depends on which product you have. Most duloxetine delayed-release capsules — including Cymbalta — must be swallowed whole. Crushing, chewing, or opening them damages the specia...
  • Can I open the capsule or crush it if I have trouble swallowing pills?
📖 Read our full Duloxetine guide →
1
Nutrient depletion considerations

Duloxetine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Duloxetine 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 Green / White / Blue
ShapeCapsule
Imprint243;60;mg
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 G4U024CQK6
    Hypromellose phthalate is a plant-derived polymer coating material. It's used to coat tablets or capsules so the medicine dissolves in the intestines rather than the stomach, protecting it from stomach acid or reducing stomach irritation.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 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.

18 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 $0.3495 $31.46 / 90 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
Duloxetine Hydrochloride 60 mg 33342-0162-07 Macleods 30 capsules $0.115 AB FDA listed —
Duloxetine 60 mg 00228-2892-03 Actavis 30 capsules $0.129 AB Availability likely —
Duloxetine 60 mg 27241-0099-03 Ajanta 30 capsules $0.129 AB Availability likely —
Duloxetine 60 mg 43547-0381-03 Solco 30 capsules $0.129 AB Availability likely —
Duloxetine Delayed-Release 60 mg 51991-0748-10 Breckenridge 1000 capsules $0.129 AB Availability likely —
Duloxetine 60 mg 68001-0596-04 BluePoint 30 capsules $0.129 AB Availability likely —
Duloxetine 60 mg 68180-0296-03 Lupin 1000 capsules $0.129 AB Availability likely —
Duloxetine 60 mg 82009-0032-10 Quallent 1000 capsules $0.129 AB Availability likely —
Duloxetine 60 mg 82009-0173-10 Quallent 1000 capsules $0.129 AB Availability likely —
Duloxetine 60 mg 00615-8496-05 NCS 15 capsules — AB FDA listed —
Duloxetine 60 mg 25000-0610-03 MARKSANS 30 capsules — — FDA listed —
Duloxetine 60 mg 31722-0170-01 Camber 100 capsules — AB FDA listed —
Duloxetine 60 mg 42708-0196-30 QPharma, 30 capsules — AB FDA listed —
Duloxetine Hydrochloride 60 mg 46708-0280-10 Alembic 100 capsules — AB FDA listed —
Duloxetine 60 mg 47335-0383-08 Sun 100 capsules — — FDA listed —
duloxetine 60 mg 49252-0009-10 Inventia 30 capsules — AB FDA listed —
Duloxetine 60 mg 50090-5940-00 A-S 30 capsules — AB FDA listed —
Duloxetine 60 mg 50090-6775-00 A-S 30 capsules — AB FDA listed —
Duloxetine 60 mg 50090-6893-00 A-S 90 capsules — AB FDA listed —
Duloxetine 60 mg 50090-7897-00 A-S 90 capsules — AB FDA listed —
Duloxetine Hydrochloride 60 mg 50771-0203-01 Yaopharma 30 capsules — — FDA listed —
Duloxetine Delayed-Release 60 mg 51407-0819-10 Golden 1000 capsules — AB FDA listed —
Duloxetine 60 mg 51655-0237-25 Northwind 60 capsules — AB FDA listed —
Duloxetine Hydrochloride 60 mg 59651-0282-30 Aurobindo 30 capsules — — FDA listed —
Duloxetine 60 mg 60760-0462-30 St. 30 capsules — AB Discontinued —
Duloxetine Hydrochloride 60 mg 62332-0280-30 Alembic 30 capsules — AB FDA listed —
Duloxetine 60 mg 63187-0666-30 Proficient 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 63187-0735-30 Proficient 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 63629-1992-01 Bryant 90 capsules — AB FDA listed —
Duloxetine 60 mg 63629-8748-01 Bryant 30 capsules — AB FDA listed —
Duloxetine 60 mgthis 65841-0801-16 Zydus 90 capsules — AB FDA listed —
Duloxetine 60 mg 67046-1598-03 Coupler 30 capsules — AB FDA listed —
Duloxetine 60 mg 67877-0265-01 Ascend 100 capsules — AB FDA listed —
Duloxetine 60 mg 68071-3519-03 NuCare 30 capsules — AB FDA listed —
Duloxetine 60 mg 68071-3775-09 NuCare 90 capsules — AB FDA listed —
Duloxetine 60 mg 68788-4026-03 Preferred 30 capsules — AB FDA listed —
Duloxetine 60 mg 68788-7672-00 Preferred 6 capsules — AB FDA listed —
Duloxetine 60 mg 68788-8623-03 Preferred 30 capsules — AB FDA listed —
duloxetine 60 mg 70247-0014-03 Qingdao 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 70518-0122-05 REMEDYREPACK 90 capsules — AB FDA listed —
Duloxetine 60 mg 70518-1011-00 REMEDYREPACK 30 capsules — AB FDA listed —
Duloxetine 60 mg 70518-1244-00 REMEDYREPACK 30 capsules — AB FDA listed —
Duloxetine 60 mg 70518-2630-01 REMEDYREPACK 30 capsules — AB Discontinued —
Duloxetine 60 mg 71205-0358-30 Proficient 30 capsules — AB FDA listed —
Duloxetine 60 mg 71335-0402-01 Bryant 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 71335-0509-01 Bryant 30 capsules — AB Discontinued —
Duloxetine 60 mg 71335-1445-01 Bryant 30 capsules — AB Discontinued —
Duloxetine 60 mg 71335-2567-01 Bryant 30 capsules — AB FDA listed —
Duloxetine 60 mg 71335-2625-01 Bryant 30 capsules — AB FDA listed —
Duloxetine 60 mg 71610-0403-60 Aphena 90 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 71610-0743-30 Aphena 30 capsules — AB FDA listed —
Duloxetine 60 mg 72162-1058-03 Bryant 30 capsules — AB FDA listed —
Duloxetine Delayed-Release 60 mg 72162-1599-01 Bryant 100 capsules — AB FDA listed —
Duloxetine D/R 60 mg 72189-0608-30 Direct_Rx 30 capsules — AB FDA listed —
Duloxetine 60 mg 72789-0338-90 PD-Rx 90 capsules — AB FDA listed —
Duloxetine 60 mg 76420-0623-01 Asclemed 100 capsules — AB FDA listed —
Duloxetine DR 60 mg 80425-0119-01 Advanced 30 capsules — AB FDA listed —
Duloxetine 60 mg 80425-0389-01 Advanced 30 capsules — AB FDA listed —
Drizalma Sprinkle 60 mg 47335-0619-10 SUN 1000 capsules — — FDA listed —
Duloxetine 60 mg 85534-0051-00 HAWAII 30 capsules — AB FDA listed —
Duloxetine 60 mg 85534-0018-00 HAWAII 30 capsules — AB FDA listed —
Duloxetine 60 mg 70954-0864-20 ANI 90 capsules — AB FDA listed —
Duloxetine 60 mg 51407-0810-10 Golden 1000 capsules — AB FDA listed —
Duloxetine 60 mg 71335-3163-01 Bryant 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

🏛️
2014
On the market since
May 2014
📍
2026
Currently FDA-listed
12 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65841-0801-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-06) 2014-05-27 Active
65841-0801-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-10) 2014-05-27 Active
65841-0801-16 You're viewing this 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-16) 2014-05-27 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65841-0801-16?
NDC 65841-0801-16 is a 90-count package — 90 capsule, delayed release in 1 bottle.
What is the difference between NDC 65841-0801-16 and NDC 65841-0801-06?
Both are Duloxetine 60 mg Capsule, Delayed Release — the drug itself is identical. NDC 65841-0801-16 is the 90-count package, while NDC 65841-0801-06 is the 30 capsules package.
What NDC number is used to bill for this package of Duloxetine 60 mg Capsule, Delayed Release?
Bill NDC 65841-0801-16 — the 11-digit billing format is 65841080116. 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 65841-801-16, 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: 65841-0801-16, written without dashes as 65841080116. 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 65841-0801-16, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0801) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 2 other package presentations of this same product, including 30 capsules (65841-0801-06), 1000 capsules (65841-0801-10). 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 6 words ▾

Manufactured by: Cadila Healthcare Ltd. India

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65841-0800-06 · Zydus 65841-0802-01 · 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.