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Duloxetine 80 mg Capsule, Delayed Release, 30-count

by Almatica Pharma LLC · 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-821-30)

NDC 52427-0821-30

🏷️ FDA NDC (as labeled) 52427-821-30 billing pads the product segment with a zero

Rx only Brand 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 Dr. Brian Staiger, PharmD

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

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 52427-821-30

Product NDC 52427-821

11-digit billing NDC 52427082130

NCPDP billing unit EA — each (per item)

RxCUI 2745865, 2745867, 2745869

UNII 9044SC542W

UPC 0352427791307, 0352427821301, 0352427913303

Application # NDA219131

SPL Set ID bb2ca3bf-983c-1e4a-a91d-dc7dee66d741

Established class (EPC) Serotonin and Norepinephrine Reuptake Inhibitor

Mechanism of action Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-07-01

Route ORAL

Dosage form CAPSULE, DELAYED RELEASE

Substance DULOXETINE HYDROCHLORIDE

Why two NDCs? The FDA registers this code as 52427-821-30 — 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 → 52427-0821-30. 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

LabelerAlmatica Pharma LLC

Application holderALMATICA PHARMA LLC

FDA applicationNDA219131 (NDA)

Labeler code52427

First marketedJul 2026

Product typeHuman Prescription Drug

Portfolio26 products on file

🔎 All NDCs from Almatica Pharma LLC

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

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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Duloxetine — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Duloxetine (132 interactions) — ranked by severity →

Nutrient depletion considerations

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

SODIUM Moderate Depletion

🧪 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 Yellow / White / Green

ShapeCapsule

ImprintALM;791

Size22 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 K848JZ4886
Cysteine is an amino acid used in medicines as a reducing agent and stabilizer. It helps protect active ingredients from oxidation and maintains product stability during storage.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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 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 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.

11 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 system	Per each	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Duloxetine 80 mgthis 52427-0821-30	Almatica	30 capsules	—	—	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

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

Jul 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic versions listed

see equivalents

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 NDC	Description	Marketing start	Status
52427-0821-30 You're viewing this	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-821-30)	2026-07-01	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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 52427-821-30, 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: 52427-0821-30, written without dashes as 52427082130. 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 52427-0821-30, the first segment (52427) is the labeler code FDA assigned to Almatica Pharma LLC; the middle segment (0821) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Almatica Pharma LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Almatica Pharma 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.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 92 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.

Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. ( 5.1 )

🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE Duloxetine Delayed-Release Capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Duloxetine Delayed-Release Capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Do not initiate treatment with Duloxetine Delayed-Release Capsules. Use another duloxetine delayed-release capsule product for initial dosage, titration, and doses below 80 mg per day. ( 2.1 ) Administer Duloxetine Delayed-Release Capsules once daily on an empty stomach at least one hour before or two hours after a meal.

Swallow whole, do not open, chew or crush. Do not sprinkle the capsule contents on food or mix with liquids. ( 2.1 ) MDD: Administer Duloxetine Delayed-Release Capsules in doses of 80 mg, 90 mg, or 120 mg.

Periodically reassess for appropriate dosing. ( 2.2 ) GAD: Administer Duloxetine Delayed-Release Capsules in doses of 90 mg or 120 mg. Periodically reassess for appropriate dosing.

( 2.3 ) The maximum dosage is 120 mg once daily ( 2.2 , 2.3 ) When discontinuing treatment, reduce dose gradually whenever possible to avoid discontinuation symptoms. Gradual dosage reduction will require use of another duloxetine delayed-release capsule product. ( 2.6 )

2.1Important Administration Instructions Do not initiate treatment with Duloxetine Delayed-Release Capsules 80 mg, 90 mg, and 120 mg. Use another duloxetine delayed-release capsule product for initial dosage, titration, and doses below 80 mg per day. Refer to the Prescribing Information of other duloxetine delayed-release capsule products for the recommended dosage of those products.

Administer Duloxetine Delayed-Release Capsules orally once daily on an empty stomach at least one hour before or two hours after a meal [see Pharmacokinetics ( 12.3 )] . Swallow whole and do not chew or crush. Do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating.

If a dose of Duloxetine Delayed-Release Capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Duloxetine Delayed-Release Capsules at the same time.

2.2Dosage for Treatment of Major Depressive Disorder Administer Duloxetine Delayed-Release Capsules in adults with MDD receiving at least 60 mg per day of another duloxetine delayed-release capsule product for one week [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . While duloxetine at a 120 mg per day dose was shown to be effective, there is no evidence that doses greater than 60 mg per day confer any additional benefits. Administer Duloxetine Delayed-Release Capsules once daily in doses of 80 mg, 90 mg, or 120 mg, titrating dose as tolerated when appropriate.

Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily.

2.3Dosage for Treatment of Generalized Anxiety Disorder Adults Less than 65 Years of Age with GAD Administer Duloxetine Delayed-Release Capsules in adults less than 65 years of age with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for one week [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.2 )] . While duloxetine at a 120 mg once daily dosage was shown to be effective, there is no evidence that doses greater than 60 mg per day confer additional benefit.

Nevertheless, if a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Administer Duloxetine Delayed-Release Capsules once daily in doses of 90 mg or 120 mg. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment.

The maximum studied dosage is 120 mg once daily. Geriatric Patients with GAD Administer Duloxetine Delayed-Release Capsules in geriatric patients with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for two weeks [see Dosage and Administration ( 2.1 ), Clinical Stud…

💊 Dosage Forms and Strengths 139 words ▾

3 DOSAGE FORMS AND STRENGTHS Duloxetine Delayed-Release Capsules are available as: 80 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque pale yellow cap and "821" printed axially on the opaque white body. Each capsule contains 89.8 mg of duloxetine hydrochloride, USP equivalent to 80 mg duloxetine. 90 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque green cap and "913" printed axially on the opaque white body.

Each capsule contains 101 mg of duloxetine hydrochloride, USP equivalent to 90 mg duloxetine. 120 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque light green cap and "791" printed axially on the opaque white body. Each capsule contains 134.7 mg of duloxetine hydrochloride, USP equivalent to 120 mg duloxetine.

Delayed-release capsules: 80 mg, 90 mg, and 120 mg ( 3 )

⛔ Contraindications 139 words ▾

4 CONTRAINDICATIONS Duloxetine Delayed-Release Capsules are contraindicated in patients who are using or within 14 days of stopping an MAOI intended to treat psychiatric disorders because of an increased risk of serotonin syndrome. Allow at least 5 days after stopping Duloxetine Delayed-Release Capsules prior to initiation of an MAOI to treat psychiatric disorders. [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.4 )]. who are using other MAOIs such as linezolid or intravenous methylene blue because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.8 ), Warnings and Precautions ( 5.4 )].

Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ) Do not start Duloxetine Delayed-Release Capsules in a patient who is being treated with linezolid or intravenous methylene blue ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue Duloxetine Delayed-Release Capsules in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease.

( 5.2 ) Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur. ( 5.3 ) Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue Duloxetine Delayed-Release Capsules and serotonergic agents.

( 5.4 ) Increased Risk of Bleeding : May increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk. ( 5.5 , 7 , 8.1 ) Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur.

Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. ( 5.6 ) Discontinuation Syndrome : Taper dose when possible and monitor for discontinuation symptoms. ( 5.7 ) Activation of Mania or Hypomania : Prior to initiating, screen patients for personal or family history of bipolar disorder, mania, or hypomania.

( 5.8 ) Angle-Closure Glaucoma : Has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.9 ) Seizures : Prescribe with care in patients with a history of seizure disorder. ( 5.10 ) Blood Pressure Increases : Monitor blood pressure prior to initiating treatment and periodically throughout treatment.

( 5.11 ) Hyponatremia : Can occur in association with SIADH; consider discontinuation. ( 5.12 ) Glucose Control in Diabetes : Worsened glycemic control has been observed. ( 5.13 ) Conditions that Slow Gastric Emptying : Use cautiously in these patients.

( 5.13 ) Sexual Dysfunction : Duloxetine Delayed-Release Capsules may cause symptoms of sexual dysfunction. ( 5.15 )

5.1Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in the antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18 to 24 5 additional patients Decreases Compared to Placebo 25 to 64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Severe Skin Reactions [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.8 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] Increases in Blood Pressure [see Warnings and Precautions ( 5.11 )] Hyponatremia [see Warnings and Precautions ( 5.12 )] Urinary Hesitation and Retention [see Warnings and Precautions ( 5.14 )] Sexual Dysfunction [see Warnings and Precautions ( 5.15 )] Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): ( 6.1 ) Adults : nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients : decreased weight, decreased appetite, nausea, vomiting, fatigue, and diarrhea To report SUSPECTED ADVERSE REACTIONS, contact Almatica Pharma LLC at 1-877-447-7979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Duloxetine Delayed-Release Capsules for the treatment for major depressive disorder (MDD) in adults and for the treatment of generalized anxiety disorder (GAD) in adults and pediatric patients is based upon adequate and well-controlled studies of another duloxetine delayed-release capsule product.

The results of these adequate and well-controlled studies of duloxetine delayed-release capsules are presented below. The stated frequencies of adverse reactions represent the proportion of patients who experienced, at least once, one treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Reactions in Adults Adult Clinical Trial Database The data described below reflect exposure to duloxetine delayed-release capsules in placebo-controlled trials for MDD (N=3779), GAD (N=1018), and other indications (N=3303). The population studied was 17 years to 89 years of age. 66% and 61% were female, and 82% and 73% were Caucasian in the MDD and GAD populations, respectively.

Most patients received duloxetine delayed-release capsules dosages of a total of 60 mg to 120 mg per day [see Clinical Studies ( 14.1 , 14.2 )] . The data below do not include results of the trial examining the efficacy of duloxetine delayed-release capsules in patients ≥ 65 years old for the treatment of generalized anxiety disorder; however, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population. Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Adult Placebo-Controlled Trials Major Depressive Disorder Approximately 8.4% (319/3779) of the duloxetine delayed-release capsules-treated patients in placebo-controlled adult trials for MDD discontinued treatment due to an adverse reaction, compared with 4.6% (117/2536) of placebo-treated patients.

Nausea (duloxetine delayed-release capsules 1.1%, placebo 0.4%) was the only adverse reaction reported as a reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong CYP1A2 inhibitors : Avoid concomitant use. ( 7.1 ) Potent inhibitors of CYP2D6 may increase Duloxetine Delayed-Release Capsule concentrations. ( 7.1 ) Duloxetine Delayed-Release Capsule is a moderate inhibitor of CYP2D6. ( 7.1 )

7.1Drugs Having Clinically Important Interactions with Duloxetine Delayed-Release Capsules Table 6: Clinically Significant Drug Interactions with Duloxetine Delayed-Release Capsules Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management Concomitant use of Duloxetine Delayed-Release Capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.7 , 2.8 ), Contraindications ( 4 ), Warnings and Precautions ( 5.4 )] . Mechanism and Clinical Effect(s) Concomitant use of SSRIs and SNRIs, including Duloxetine Delayed-Release Capsules, with MAOIs increases the risk of serotonin syndrome.

Other Serotonergic Drugs Prevention or Management Monitor for symptoms of serotonin syndrome when Duloxetine Delayed-Release Capsules is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of Duloxetine Delayed-Release Capsules and/or concomitant serotonergic drugs [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.4 )] . Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with other serotonergic drugs increases the risk of serotonin syndrome.

Alcohol Prevention or Management Avoid use in patients with chronic liver disease or heavy alcohol use [see Warnings and Precautions ( 5.2 )] . Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules and alcohol may cause liver injury or aggravate pre-existing liver disease. Drugs that Interfere with Hemostasis Prevention or Management Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when Duloxetine Delayed-Release Capsules are initiated or discontinued [Warnings and Precaution ( 5.5 )] .

Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. Strong CYP1A2 Inhibitors Prevention or Management Avoid concomitant use of Duloxetine Delayed-Release Capsules with strong CYP1A2 inhibitors [see Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with CYP1A2 inhibitors increase the exposures of duloxetine.

Strong CYP2D6 Inhibitors Prevention or Management Monitor for adverse events and adjust the dose of Duloxetine Delayed-Release Capsules as clinically appropriate when co-administering with strong CYP2D6 inhibitors [see Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with CYP2D6 inhibitors increase the exposures of duloxetine. Greater degrees of inhibition are expected with higher doses of CYP2D6 inhibitors.

CYP2D6 Poor Metabolizers Using Strong Inhibitor of CYP1A2 Prevention or Management Avoid co-administration of Duloxetine Delayed-Release Capsules and strong CYP1A2 inhibitors in patients who are CYP2D6 poor metabolizers [see Clinical Pharmacology ( 12.3 )] . Mechanism and Clinical Effect(s) Concomitant administration of Duloxetine Delayed-Release Capsules with strong CYP1A2 inhibitors in patients who are CYP2D6 poor metabolizers results in increased duloxetine exposures. Drugs Metabolized by CYP2D6 Prevention or Management Monitor plasma concentrations of CYP2D6 substrate and reduce dosage of CYP2D6 substrate drug if necessary [see Clinical Pharmacology ( 12.3 )] .

Mechanism and Clinical Effect(s) Concomitant use of duloxetine increases exposures of a drug primarily metabolized by CYP2D6 which may increase the risk of toxicity of the CYP2D6 substrate drug. Drugs Metabolized by CYP1A2 Prevention or M…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate. ( 8.1 ) Hepatic Impairment : Avoid use in patients with chronic liver disease or cirrhosis. ( 8.6 ) Renal Impairment : Avoid use in patients with severe renal impairment, GFR <30 mL/minute. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to antidepressants, including Duloxetine Delayed-Release Capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage.

Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data) . There are risks associated with untreated depression in pregnancy, and with exposure to SNRIs and SSRIs, including Duloxetine Delayed-Release Capsules, during pregnancy (see Clinical Considerations). In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 times and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m 2 basis.

When duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the MRHD given to adolescents on a mg/m 2 basis. At this dose, pup behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity were observed. Post-weaning growth was not adversely affected.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Maternal Adverse Reactions Use of Duloxetine Delayed-Release Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5 )]. Fetal/Neonatal Adverse Reaction Neonates exposed to duloxetine and other SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.

🤰 Pregnancy ~3 min read ▾

Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions ( 5.4 )] .

Data Human Data Data from a postmarketing retrospective claims-based cohort study found an increased risk for postpartum hemorrhage among 955 pregnant women exposed to duloxetine in the last month of pregnanc…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Antidepressants increased the risk of suicidal thoughts and behavior in pediatric patients. Monitor all pediatric patients being treated with antidepressants for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment, or at times of dosage changes [see Warnings and Precautions ( 5.1 )] . Perform regular monitoring of weight and growth in pediatric patients treated with Duloxetine Delayed-Release Capsules [see Adverse Reactions ( 6.1 )] .

Generalized Anxiety Disorder The safety and effectiveness of Duloxetine Delayed-Release Capsules for the treatment of generalized anxiety disorder (GAD) in patients 7 years to 17 years of age is based upon an adequate and well‑controlled study of another duloxetine delayed-release capsule product. Use of Duloxetine Delayed-Release Capsules for this indication is supported by evidence from a single 10-week, placebo-controlled trial (Study 6) in 272 patients aged 7 to 17 years with GAD. Duloxetine delayed-release capsules demonstrated superiority over placebo as measured by greater improvement in the Pediatric Anxiety Rating Scale (PARS) for GAD severity score [see Clinical Studies ( 14.2 )].

The safety and effectiveness of Duloxetine Delayed-Release Capsules for the treatment of GAD have not been established in pediatric patients less than 7 years of age. Major Depressive Disorder The safety and effectiveness of Duloxetine Delayed-Release Capsules have not been established in pediatric patients for the treatment of MDD. Effectiveness was not demonstrated in two adequate and well controlled trials conducted in 800 pediatric patients aged 7 years to 17 years with MDD.

Neither duloxetine delayed-release capsules nor an active control approved for treatment of pediatric MDD were superior to placebo in the 10-week trials. The most frequently observed adverse reactions in the MDD pediatric clinical trials included nausea, headache, decreased weight, and abdominal pain. Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs.

Juvenile Animal Toxicology Data Duloxetine administration to young rats from post-natal day 21 (weaning) through post-natal day 90 (adult) resulted in decreased body weights that persisted into adulthood, but recovered when drug treatment was discontinued; slightly delayed (~1.5 days) sexual maturation in females, without any effect on fertility; and a delay in learning a complex task in adulthood, which was not observed after drug treatment was discontinued. These effects were observed at the high dose of 45 mg/kg/day (2 times the MRHD, for a child); the no-effect-level was 20 mg/kg/day (≈1 times the MRHD, for a child).

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Geriatric Exposure in Premarketing Clinical Trials of Duloxetine Of the 2,418 patients in MDD trials, 6% (143) were 65 years of age or over. In the MDD and GAD studies, no overall differences in safety or effectiveness were generally observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between these geriatric and younger adult patients, but greater sensitivity of some older patients cannot be ruled out. SSRIs and SNRIs, including Duloxetine Delayed-Release Capsules, have been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.12 )] .

In an analysis of data from all placebo-controlled trials, patients treated with duloxetine reported a higher rate of falls compared to placebo-treated patients. The increased risk appears to be proportional to a patient’s underlying risk for falls. Underlying risk appears to increase steadily with age.

As geriatric patients tend to have a higher prevalence of risk factors for falls such as medications, medical comorbidities and gait disturbances, the impact of increasing age by itself on falls during duloxetine treatment is unclear. Falls with serious consequences including bone fractures and hospitalizations have been reported with duloxetine use [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . The pharmacokinetics of duloxetine after a single dose of 40 mg were compared in healthy elderly females (65 years to 77 years) and healthy middle-age females (32 years to 50 years).

There was no difference in the C max , but the area under the concentration-time curve (AUC) of duloxetine was somewhat (about 25%) higher and the half-life about 4 hours longer in the elderly females. Population pharmacokinetic analyses suggest that the typical values for clearance decrease by approximately 1% for each year of age between 25 years to 75 years of age; but age as a predictive factor only accounts for a small percentage of between-patient variability. Dosage adjustment based on the age of the adult patient is not necessary.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE

10.1Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute duloxetine overdoses, primarily with mixed overdoses, but also with duloxetine only, including 1000 mg of duloxetine (approximately 8.3 times the maximum recommended dosage). Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting.

10.2Management of Overdose There is no specific antidote to a duloxetine overdosage, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose with Duloxetine Delayed-Release Capsules, treatment should consist of those general measures employed in the management of overdose with any drug, such as assuring an adequate airway, oxygenation, and ventilation and monitoring cardiac rhythm and vital signs. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.

Induction of emesis is not recommended. Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract. Administration of activated charcoal has been shown to decrease duloxetine AUC and C max by an average of one-third, although some patients had a limited effect of activated charcoal.

Due to the large volume of distribution of duloxetine, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial. In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who overdose with Duloxetine Delayed-Release Capsules and tricyclic antidepressants.

In such a case, decreased clearance of the parent tricyclic and/or its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7 )] . Consider contacting a Poison Help line (1-800-222-1222 or www.poison.org) for additional information on the treatment of overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

12.2Pharmacodynamics Preclinical studies have shown that duloxetine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake and a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro . Duloxetine does not inhibit monoamine oxidase (MAO).

Duloxetine is in a class of drugs known to affect urethral resistance [see Warnings and Precautions ( 5.14 )] . Cardiac Electrophysiology The effect of duloxetine 160 mg and 200 mg administered twice daily (2.7 times and 3.3 times the maximum recommended dosage, respectively) to steady state was evaluated in a randomized, double-blinded, two-way crossover study in 117 healthy female adult subjects. No QT interval prolongation was detected.

Duloxetine appears to be associated with concentration-dependent but not clinically meaningful QT shortening. Alcohol When duloxetine and ethanol were administered several hours apart so that peak concentrations of each would coincide, duloxetine did not increase the impairment of mental and motor skills caused by alcohol.

12.3Pharmacokinetics No clinically significant difference in duloxetine exposure was observed following oral administration of either duloxetine delayed-release capsules or Duloxetine Delayed-Release Capsules. Duloxetine pharmacokinetics are dose proportional over the therapeutic range. Steady-state plasma concentrations are typically achieved after 3 days of dosing.

Absorption After oral duloxetine delayed-release capsules administration, the median lag time of absorption (T lag ) is 2 hours and maximal plasma concentrations (C max ) of duloxetine occurs at 6 hours post dose. There is a 3-hour delay in absorption and a one-third increase in apparent clearance of duloxetine after an evening dose as compared to a morning dose. Effect of Food Food delays the median time to reach peak concentration from 6 to 8 hours.

Administration of Duloxetine Delayed-Release Capsules to healthy subjects with a high-fat meal (containing 1000 calories, 50% fat) increased C max and area under the plasma concentration-time curve (AUC inf ) by 29% and 35%, respectively, compared to the fasted state. Distribution The apparent volume of distribution averages about 1640 L. Duloxetine is highly bound (>90%) to proteins in human plasma, binding primarily to albumin and α 1 -acid glycoprotein.

The interaction between duloxetine and other highly protein bound drugs has not been fully evaluated. Plasma protein binding of duloxetine is not affected by renal or hepatic impairment. Elimination Duloxetine has an elimination half-life of about 12 hours (range 8 hours to 17 hours).

Elimination of duloxetine is mainly through hepatic metabolism involving two P450 isozymes, CYP1A2 and CYP2D6. Metabolism Biotransformation and disposition of duloxetine in humans have been determined following oral administration of 14 C-labeled duloxetine. Duloxetine comprises about 3% of the total radiolabeled material in the plasma, indicating that it undergoes extensive metabolism to numerous metabolites.

The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Both CYP1A2 and CYP2D6 catalyze the oxidation of the naphthyl ring in vitro . Metabolites found in plasma include 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate.

Excretion Many additional metabolites have been identified in urine, some representing only minor pathways of elimination. Only trace (less than 1% of the dose) amounts of unchanged duloxetine are present in the urine. M…

🧬 Mechanism of Action 41 words ▾

📦 How Supplied / Storage and Handling 184 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Duloxetine Delayed-Release Capsules are available as: 80 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque pale yellow cap and "821" printed axially on the opaque white body. Each capsule contains 89.8 mg of duloxetine hydrochloride, USP equivalent to 80 mg duloxetine. NDC 52427-821-30, bottle of 30 capsules with a child-resistant closure 90 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque green cap and "913" printed axially on the opaque white body.

Each capsule contains 101 mg of duloxetine hydrochloride, USP equivalent to 90 mg duloxetine. NDC 52427-913-30, bottle of 30 capsules with a child-resistant closure 120 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque light green cap and "791" printed axially on the opaque white body. Each capsule contains 134.7 mg of duloxetine hydrochloride, USP equivalent to 120 mg duloxetine.

NDC 52427-791-30, bottle of 30 capsules with a child-resistant closure Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 201 words ▾

11 DESCRIPTION Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-( S )-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.88.

The structural formula is: Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively).

These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide.

The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Administration Advise patients to take Duloxetine-Delayed Release Capsules on an empty stomach at least one hour before or two hours after a meal and to swallow Duloxetine Delayed-Release Capsules whole and to not chew, crush, or open the capsule (do not sprinkle contents on food or mixed with liquids) because these actions might affect the enteric coating.

Hepatotoxicity Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with Duloxetine Delayed-Release Capsules. Instruct patients to talk to their healthcare provider immediately if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking Duloxetine Delayed-Release Capsules, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption.

Use of Duloxetine Delayed-Release Capsules with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2 )] . Alcohol Although Duloxetine Delayed-Release Capsules does not increase the impairment of mental and motor skills caused by alcohol, use of Duloxetine Delayed-Release Capsules concomitantly with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] . Orthostatic Hypotension, Falls and Syncope Advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of Duloxetine Delayed-Release Capsules [see Warnings and Precautions ( 5.3 )] .

Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the concomitant use of Duloxetine Delayed-Release Capsules and other serotonergic agents including triptans, tricyclic antidepressants, opioids, lithium, buspirone, tryptophan, amphetamines, and St. John’s Wort [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.1 )] . Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Caution patients to seek medical care immediately if they experience these symptoms. Increased Risk of Bleeding Caution patients about the concomitant use of Duloxetine Delayed-Release Capsules and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.1 )] . Severe Skin Reactions Caution patients that Duloxetine Delayed-Release Capsules may cause serious skin reactions.

This may need to be treated in a hospital and may be life-threatening. Counsel patients to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Warnings and Precautions ( 5.6 )] . Discontinuation of Treatment Instruct patients that discontinuation of Duloxetine Delayed-Release Capsules may be a…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE DULOXETINE (doo lox e teen) DELAYED-RELEASE CAPSULES, for oral use What is the most important information I should know about Duloxetine Delayed-Release Capsules? Duloxetine Delayed-Release Capsules may cause serious side effects, including: Increased risk of suicidal thoughts and actions. Duloxetine Delayed-Release Capsules and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings, or if you develop suicidal thoughts or actions.

This is very important when an antidepressant medicine is started or when the dose is changed. Tell your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled.

Tell your healthcare provider between visits as needed, especially if you have concerns about symptoms. Tell your healthcare provider or get emergency help right away if you or your family member taking Duloxetine Delayed-Release Capsules have any of the following symptoms, especially if they are new, worse, or worry you: suicide attempts acting aggressive, being angry, or violent new or worse depression panic attacks new or worse irritability an extreme increase in activity or talking (mania) thoughts about suicide or dying acting on dangerous impulses new or worse anxiety feeling very agitated or restless trouble sleeping other unusual changes in behavior or mood See “ What are the possible side effects of Duloxetine Delayed-Release Capsules?” for more information about side effects.

What are Duloxetine Delayed-Release Capsules? Duloxetine Delayed-Release Capsules are a prescription medicine used to treat: a certain type of depression called major depressive disorder (MDD) in adults generalized anxiety disorder (GAD) in adults and children 7 years of age and older It is not known if Duloxetine Delayed-Release Capsules are safe and effective for use in children under 7 years of age with GAD. It is not known if Duloxetine Delayed-Release Capsules are safe and effective for use in children with MDD or other health conditions.

Who should not take Duloxetine Delayed-Release Capsules? Do not take Duloxetine Delayed-Release Capsules if you are taking, or have stopped taking within the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI) including the antibiotic linezolid or intravenous methylene blue. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 5 days after you stop treatment with Duloxetine Delayed-Release Capsules. Before taking Duloxetine Delayed-Release Capsules tell your healthcare provider about all your medical conditions, including if you: have, or have a family history of suicide, bipolar disorder, depression, mania or hypomania have liver or kidney problems drink alcohol have or had bleeding problems have glaucoma (high pressure in the eye) have or had seizures (convulsions) have high or low blood pressure have diabetes or high blood sugar have or had heart problems have low sodium levels in your blood have slow stomach emptying have problems urinating (hesitation) or emptying your bladder (urinary retention) are pregnant or plan to become pregnant.

Duloxetine Delayed-Release Capsules may harm your unborn baby. Taking Duloxetine Delayed-Release Capsules during the third trimester of pregnancy may cause you to have an increased risk of bleeding after your delivery and m…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

depression: A lasting low mood with loss of interest that affects everyday life.

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

enteric-coated: A special coating that keeps a pill from dissolving in the stomach, so it opens up further along in the intestine.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypomania: A milder form of mania, with raised energy and mood that is less severe and shorter-lasting than a full manic episode.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myoclonus: Sudden, brief, jerking movements of a muscle or group of muscles.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

postpartum: The period of time right after a woman gives birth.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

relapse: The return of a cancer after a period of improvement or disappearance.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

SIADH: Syndrome of inappropriate antidiuretic hormone: the body makes too much of a water-holding hormone, which lowers the level of sodium (salt) in the blood.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

strong inhibitor: A substance that blocks an enzyme very powerfully, causing a large rise in the levels of affected drugs.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urinary retention: Being unable to empty the bladder fully or at all.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 52427-0806-90 · Almatica 52427-0850-60 · Almatica →

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.

Duloxetine 80 mg Capsule, Delayed Release, 30-count

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