Home › NDC Lookup › Ingredients › Doxepin Hydrochloride › 48433-0035-20

Doxepin Hydrochloride 10 mg Capsule, 100-count

by Safecor Health, LLC · 100 BLISTER PACK in 1 CARTON (48433-035-20) / 1 CAPSULE in 1 BLISTER PACK (48433-035-01)

NDC 48433-0035-20

🏷️ FDA NDC (as labeled) 48433-035-20 billing pads the product segment with a zero

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 Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Doxepin Hydrochloride (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Jul 25, 2025 — CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. (Alembic Pharmaceuticals Limited) · FDA recall D-0566-2025

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

🆔 Identity & classification

FDA NDC (as labeled) 48433-035-20

Product NDC 48433-035

11-digit billing NDC 48433003520

NCPDP billing unit EA — each (per item)

RxCUI 1000048, 1000058, 1000070, 1000076

UNII 3U9A0FE9N5

Application # ANDA070791

SPL Set ID a2297f75-c498-419b-aa29-057271313a7f

Established class (EPC) Tricyclic Antidepressant

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-02-23

Route ORAL

Dosage form CAPSULE

Substance DOXEPIN HYDROCHLORIDE

GCN Seq No 046086

GCN 16563

HICL code 001650

Ingredient (HICL) Doxepin Hcl

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H2

Therapeutic class — intermediate (HIC2) Psychoactive Drugs

HIC3 code H2U

Therapeutic class — specific (HIC3) Tricyclic Antidepressants,Rel.non-Sel.reupt-Inhib

AHFS code 28:16.04.28

AHFS class Tricyclics, Other Norepi-Ru Inhibitors

FDB label name DOXEPIN 10 MG CAPSULE

FDB brand name Doxepin Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 48433-035-20 — 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 → 48433-0035-20. 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 Tricyclic Antidepressant class.

Pharmacologic class Tricyclic Antidepressant

Drug family (ATC) Other antipruritics, Non-selective monoamine reuptake 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

LabelerSafecor Health, LLC

Application holderMYLAN PHARMACEUTICALS INC

FDA applicationANDA070791 (ANDA)

Labeler code48433

First marketedFeb 2026

Product typeHuman Prescription Drug

Portfolio55 products on file

🔎 All NDCs from Safecor Health, 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

Label name DOXEPIN 10 MG CAPSULE Ingredient Doxepin Hcl

📗 Our plain-language guide HelloPharmacist

Good question — doxepin does have a history as an antidepressant, but what you're being prescribed is a much lower-dose version specifically approved for sleep. It's used for peopl...
What exactly is doxepin being used for here? I thought it was an antidepressant.
Yes, timing really does matter. You should take doxepin at least 3 hours after your last meal — especially if that meal was high in fat. Eating close to your dose makes the medicat...
Does it matter when I take it or if I eat first?

📖 Read our full Doxepin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

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

SODIUM Moderate Depletion

🧪 Full Doxepin nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white / green

ShapeCapsule

ImprintMYLAN;6410

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 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 CQ3XH3DET6
D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
UNII J9EQA3S2JM
FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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 H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 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 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 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 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.

16 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 · Q2 2026	$0.4302	$43.02 / 100 capsule

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
Doxepin Hydrochloride 10 mg 00378-1049-01	Mylan	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 00904-7052-61	Major	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 23155-0794-01	Heritage	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 24658-0793-01	PURACAP	100 capsules	$0.078	AB	Availability likely	—
Doxepin hydrochloride 10 mg 27241-0167-01	Ajanta	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 42806-0529-01	Epic	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 51079-0436-20	Mylan	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 59651-0173-01	Aurobindo	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 62135-0560-90	Chartwell	90 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 62332-0637-31	Alembic	100 capsules	$0.078	AB	Availability likely	—
Doxepin hydrochloride 10 mg 64980-0594-01	Rising	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 70756-0424-11	Lifestar	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 71921-0162-01	Florida	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 72205-0088-91	Novadoz	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 72603-0390-01	NorthStar	100 capsules	$0.078	AB	Availability likely	—
Doxepin Hydrochloride 10 mg 69315-0158-01	Leading	100 capsules	$0.100	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 69238-1166-01	Amneal	1000 capsules	$0.208	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 10267-5059-04	Contract	1000 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 42571-0420-01	Micro	100 capsules	—	AB	Discontinued	—
Doxepin Hydrochloride 10 mg 43353-0329-09	Aphena	9000 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 46708-0637-31	Alembic	100 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mgthis 48433-0035-20	Safecor	100 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 55801-0527-01	Appco	100 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 67296-2165-02	Redpharm	20 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 68071-5179-09	NuCare	90 capsules	—	AB	FDA listed	—
Doxepin hydrochloride 10 mg 70518-3594-00	REMEDYREPACK	30 capsules	—	AB	Discontinued	—
Doxepin Hydrochloride 10 mg 70518-4252-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 71205-0534-30	Proficient	30 capsules	—	AB	FDA listed	—
Doxepin hydrochloride 10 mg 71205-0695-30	Proficient	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 71335-0072-01	Bryant	30 capsules	—	AB	FDA listed	—
Doxepin hydrochloride 10 mg 71335-2092-01	Bryant	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 71335-2452-01	Bryant	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 71335-2647-01	Bryant	30 capsules	—	AB	FDA listed	—
Doxepin HCL 10 mg 72189-0355-30	Direct_Rx	30 capsules	—	—	FDA listed	—
Doxepin HCL 10 mg 72189-0574-30	Direct_rx	30 capsules	—	AB	FDA listed	—
Doxepin HCL 10 mg 72189-0590-30	Direct_rx	30 capsules	—	AB	FDA listed	—
Doxepin HCL 10 mg 72189-0633-30	Direct_Rx	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 72789-0072-30	PD-Rx	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 72789-0220-30	PD-Rx	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 81469-0415-01	First	100 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 83209-0424-30	Boswell	30 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 50090-8009-00	A-S	90 capsules	—	AB	FDA listed	—
Doxepin Hydrochloride 10 mg 82804-0305-30	Proficient	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

🏛️

2026

On the market since

Feb 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Doxepin hydrochloride — the ingredient across all brands.

Top reported reactions

Toxicity To Various Agents988

Completed Suicide828

Fatigue793

Pain755

Nausea679

Headache642

Insomnia622

Age at onset

Neonate21

Infant5

Child31

Adolescent21

Adult1,586

Elderly638

Reporter sex

Serious outcomes

Hospitalization3,570

Death2,172

Life-threatening540

Disabling295

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
48433-0035-20 You're viewing this	100 BLISTER PACK in 1 CARTON (48433-035-20) / 1 CAPSULE in 1 BLISTER PACK (48433-035-01)	2026-02-23	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 48433-035-20, 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: 48433-0035-20, written without dashes as 48433003520. 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 48433-0035-20, the first segment (48433) is the labeler code FDA assigned to Safecor Health, LLC; the middle segment (0035) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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 Safecor Health, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Safecor Health, 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 121 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase 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) ]. Doxepin hydrochloride capsules are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ].

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behaviors in pediatric and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Doxepin hydrochloride capsules are not approved for use in pediatric patients ( 8.4 )

🎯 Indications and Usage 41 words ▾

1 INDICATIONS AND USAGE Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 ) Recommended starting oral dosage is 25 mg three times daily or 75 mg once daily. ( 2.2 ) Recommended target total dosage range is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses).

( 2.2 ) Maximum recommended dosage is 100 mg three times daily. ( 2.2 ) Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules. ( 2.3 ) See the Full Prescribing Information for dosage modifications intended to reduce the risk of anticholinergic effects, for strong CYP2D6 inhibitors, and in known CYP2D6 and CYP2C19 poor metabolizers.

( 2.4 , 2.5 , 2.6 ). When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued. ( 2.7 )

2.1Screen for Bipolar Disorder Prior to Starting Doxepin Hydrochloride Capsules Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.5) ].

2.2Recommended Dosage The recommended starting oral dosage for doxepin hydrochloride capsules is 25 mg three times daily or 75 mg once daily. The recommended target total oral dosage range for doxepin hydrochloride capsules is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). The maximum recommended oral dosage for doxepin hydrochloride capsules is 100 mg three times daily.

2.3Switching Patients to or from a Monoamine Oxidase Inhibitor Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules [see Contraindications (4) , Warnings and Precautions (5.2) , and Drug Interactions (7) ] . Wait at least 14 days after discontinuation of doxepin hydrochloride capsules before initiating therapy with an MAOI [see Contraindications (4) , Warnings and Precautions (5.2) , and Drug Interactions (7) ].

2.4Dosage Modifications Intended to Reduce the Risk of Anticholinergic Effects If anticholinergic effects (e.g., dry mouth, blurred vision, constipation) develop, reduce the doxepin hydrochloride capsules dosage [see Adverse Reactions (6.1) ].

2.5Dosage Modifications for Strong CYP2D6 Inhibitors Reduce the doxepin hydrochloride capsules dosage based on doxepin plasma concentrations when used concomitantly with strong CYP2D6 inhibitors [see Drug Interactions (7) ].

2.6Dosage Modifications in Known CYP2D6 and CYP2C19 Poor Metabolizers Reduce the doxepin hydrochloride capsules dosage based on doxepin plasma concentrations in patients who are known CYP2D6 and CYP2C19 poor metabolizers [see Use in Specific Populations (8.7) ].

2.7Discontinuation of Doxepin Hydrochloride Capsules Treatment When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued [see Adverse Reactions (6) ] .

💊 Dosage Forms and Strengths 216 words ▾

3 DOSAGE FORMS AND STRENGTHS Doxepin Hydrochloride Capsules, USP are available containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of doxepin. The 10 mg capsules are hard-shell, gelatin capsules with a buff opaque cap and buff opaque body axially printed with MYLAN over 1049 in black ink on both the cap and the body. The 25 mg capsules are hard-shell, gelatin capsules with an ivory opaque cap and white opaque body axially printed with MYLAN over 3125 in black ink on both the cap and the body.

The 50 mg capsules are hard-shell, gelatin capsules with an ivory opaque cap and ivory opaque body axially printed with MYLAN over 4250 in black ink on both the cap and the body. The 75 mg capsules are hard-shell, gelatin capsules with a brite lite green opaque cap and brite lite green opaque body axially printed with MYLAN over 5375 in black ink on both the cap and the body. The 100 mg capsules are hard-shell, gelatin capsules with a brite lite green opaque cap and white opaque body axially printed with MYLAN over 6410 in black ink on both the cap and the body.

Capsules: 10 mg, 25 mg, 50 mg, 75 mg and 100 mg ( 3 )

⛔ Contraindications 118 words ▾

4 CONTRAINDICATIONS Doxepin hydrochloride capsules are contraindicated in patients: With hypersensitivity to doxepin (hypersensitivity reactions have included tongue edema and urticaria). The possibility of cross sensitivity with other dibenzoxepines should be kept in mind. With glaucoma [see Warnings and Precautions (5.3) ].

With current or past urinary retention [see Adverse Reactions (6.1) ]. Taking MAOIs, or within 14 days of stopping MAOIs (including the MAOIs linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7) ]. Hypersensitivity to doxepin ( 4 ) Glaucoma ( 4 ) Current or past urinary retention ( 4 ) Taking MAOIs, or within 14 days of stopping MAOIs ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Suicidal Thoughts and Behaviors : Monitor for clinical worsening and suicide thoughts and behaviors. Consider changing the therapeutic regimen, including possibly discontinuing doxepin hydrochloride capsules, in patients who are experiencing emergent suicidal thoughts or behaviors. ( 5.1 ) Serotonin Syndrome : Risk increases with concomitant use of other serotonergic drugs.

Monitor all patients taking doxepin hydrochloride capsules for the emergence of serotonin syndrome. Discontinue doxepin hydrochloride capsules and any concomitant serotonergic agents immediately and initiate supportive treatment if serotonin syndrome occurs. ( 5.2 , 7 ) Angle-Closure Glaucoma : Avoid use of doxepin hydrochloride capsules in patients with untreated anatomically narrow angles.

( 5.3 ) Sedation and Driving Risks : Because doxepin hydrochloride capsules can cause sedation, warn patients against driving a car or operating dangerous machinery while taking doxepin hydrochloride capsules. ( 5.4 ) Activation of Mania or Hypomania : Prior to initiating antidepressant therapy, screen for bipolar disorder. Doxepin hydrochloride capsules are not approved for use in treating bipolar depression.

( 5.5 )

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs including tricyclic antidepressants and other antidepressant classes that included approximately 77,000 adult patients and 4,500 pediatric patients (doxepin hydrochloride capsules are not approved for use in pediatric patients), the incidence of suicidal thoughts and behaviors in 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. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors 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 1,000 Patients Treated Increases Compared to Placebo < 18 years old 14 additional patients 18-24 years old 5 additional patients Decreases Compared to Placebo 25-64 years old 1 fewer patient ≥ 65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric 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. Monitor all doxepin hydrochloride capsules-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of doxepin hydrochloride capsules therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the health care provider.

Consider changing the therapeutic regimen, including possibly discontinuing doxepin hydrochloride capsules, in patients who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome Tricyclic antidepressants, including doxepin hydrochloride capsules, can precipitate serotonin syndrome, a potentially life-threatening condition. This risk is increased with concomitant use of other serotonergic drugs (e.g., other tricyclic antidepressants, SSRIs, serotonin norepinephrine reuptake inhibitors, triptans, tetracyclic antidepressants, opioids), lithium, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (e.g., MAOIs intended to treat psychiatric disorders and others, such as linezolid or intravenous…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.3) ] Sedation and Driving Risks [see Warnings and Precautions (5.4) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.5) ] Risk of Seizures [see Warnings and Precautions (5.6) ] Psychosis [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue.

( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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. Adverse reactions (≥ 2% of doxepin-treated patients) in 1,635 doxepin-treated patients with MDD in clinical trials included somnolence (17%), dry mouth (15%), dizziness (6%), constipation (5%), fatigue (5%), blurred vision (3%), tachycardia (3%), hypotension (3%), insomnia (2%), tremor (2%), nausea (2%), hyperhidrosis (2%), and increased weight (2%).

Other Adverse Reactions Observed in Clinical Trials Other adverse reactions that occurred at an incidence of < 2% in patients treated with doxepin in clinical trials were: Ear and Labyrinth Disorders : Tinnitus. Gastrointestinal Disorders : Diarrhea, dyspepsia, vomiting. General Disorders and Administration Site Conditions : Asthenia, edema, chills.

Metabolism and Nutrition Disorders : Decreased appetite. Nervous System Disorders : Ataxia, paresthesia, headache, extrapyramidal disorder. Psychiatric Disorders : Agitation, confusional state, libido decreased.

Pulmonary Disorders : Asthma exacerbation. Renal and Urinary Disorders : Urinary retention. Reproductive System and Breast Disorders : Breast enlargement.

Skin & Subcutaneous Tissue Disorders : Rash, pruritus. Vascular Disorders : Flushing.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of doxepin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders : Agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, purpura.

Cardiac Disorders : Conduction disorder, arrhythmia. Endocrine Disorders : Inappropriate antidiuretic hormone secretion. Eye Disorders : Angle-closure glaucoma, mydriasis.

Gastrointestinal Disorders : Aphthous stomatitis, abdominal pain upper. General Disorders and Administration Site Conditions : Facial edema, hyperpyrexia. Hepatobiliary Disorders : Jaundice.

Investigations : Blood glucose increased. Nervous System Disorders : Hypoesthesia, dysgeusia, convulsion, tardive dyskinesia, serotonin syndrome. Psychiatric Disorders : Hallucination, disorientation.

Reproductive System and Breast Disorders : Testicular swelling, gynecomastia, galactorrhea. Skin and Subcutaneous Tissue Disorders : Photosensitivity reaction, tongue edema, alopecia, urticaria. Vascular Disorders : Hypertension.

Withdrawal syndrome occurred after stopping doxepin [see Drug Abuse and Dependence (9.3) ]. The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 2 describe the clinically significant drug interactions of doxepin hydrochloride capsules with other drugs or classes. Table 2: Clinically Significant Drug Interactions with Doxepin Hydrochloride Capsules Monoamine Oxidase Inhibitors Prevention or Management Doxepin hydrochloride capsules are contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue. The use of doxepin hydrochloride capsules within 14 days of discontinuation of an MAOI or the use of MAOI within 14 days of discontinuation of doxepin hydrochloride capsules is contraindicated .

Starting doxepin hydrochloride capsules in a patient who is being treated with an MAOI is contraindicated . Clinical Effect(s) Concomitant use of doxepin hydrochloride capsules and MAOIs increases the risk of serotonin syndrome [ Warnings and Precautions (5.2) ] . Other Serotonergic Drugs (Besides MAOIs) Prevention or Management Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases.

If serotonin syndrome occurs, consider discontinuation of doxepin hydrochloride capsules and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ]. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride capsules with other serotonergic drugs increases the risk of serotonin syndrome [see Warnings and Precautions (5.2) ]. Strong CYP2D6 Inhibitors Prevention or Management Monitor doxepin plasma concentrations and reduce the doxepin hydrochloride capsules dosage or the strong CYP2D6 inhibitor as appropriate [see Dosage and Administration (2.5) ].

Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride capsules with strong CYP2D6 inhibitors may increase the exposures of doxepin [see Clinical Pharmacology (12.3) ] which may increase the risk of doxepin hydrochloride capsules related adverse reactions [see Warnings and Precautions (5) and Adverse Reactions (6) ]. Examples See www.fda.gov/CYPandTransporterInteractingDrugs for examples of strong CYP2D6 Inhibitors. Carbamazepine Prevention or Management Monitor doxepin plasma concentrations and consider increasing the doxepin hydrochloride capsules dosage in patients taking carbamazepine.

Mechanism and Clinical Effect(s) Concomitant use of carbamazepine with doxepin hydrochloride capsules decreases the exposure of doxepin [see Clinical Pharmacology (12.3) ] which could lead to reduced treatment effect. Cimetidine Prevention or Management Monitor doxepin plasma concentrations and consider reducing the doxepin hydrochloride capsules dosage in patients taking cimetidine. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride capsules with cimetidine may increase the exposures of doxepin [see Clinical Pharmacology (12.3) ] which may increase the risk of doxepin hydrochloride capsules-related anticholinergic effects (e.g., dry mouth, blurred vision, constipation) [see Adverse Reactions (6.1) ].

Alcohol Prevention or Management Avoid concomitant use with alcohol. Mechanism and Clinical Effect(s) Doxepin hydrochloride capsules may potentiate the sedative effects of alcohol [see Warnings and Precautions (5.4) ] . CNS Depressants Prevention or Management Dosage reduction of doxepin hydrochloride capsules and/or the CNS depressant may be needed based on clinical response and tolerability.

Mechanism and Clinical Effect(s) When concomitantly administered with doxepin hydrochloride capsules, the sedative effects of CNS depressant may be potentiated [see Warnings and Precautions (5.4) ] . Tolazamide Prevention or Management Monitor glucose levels and reduce the doxepin hydrochloride capsules dosage as appropriate. Clinical Effect(s) Doxepin hydrochloride capsules may cause severe hypoglycemia when concomitantly used with tolazamide.

Serotonergic Drugs : Monitor patients for signs and symptoms of serotonin syndrome, particularly during trea…

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Neonates exposed to TCAs, including doxepin hydrochloride capsules, late in the third trimester have developed poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability). Monitor neonates who were exposed to doxepin hydrochloride capsules in the third trimester of pregnancy for poor neonatal adaptation syndrome. ( 8.1 ) Lactation : Breastfeeding not recommended.

( 8.2 ) Geriatric Use : May cause confusion and oversedation. ( 8.5 ) CYP2C19 and CYP2D6 Poor Metabolizers : Increased risk of doxepin hydrochloride capsule-associated adverse reactions. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including doxepin hydrochloride capsules, during pregnancy. Health care providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants. Risk Summary Available data from published epidemiological studies and postmarketing reports have not established an increased risk for major birth defects or miscarriage with doxepin hydrochloride capsules use (see Data ).

There are risks (see Clinical Considerations ) : To the mother associated with untreated depression in pregnancy. Poor neonate adaptation from exposure to tricyclic antidepressants (TCAs), including doxepin hydrochloride capsules, during the third trimester of pregnancy . Animal reproduction toxicity of doxepin has not been fully characterized.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major 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 Embryofetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of MDD than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of MDD who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated MDD when considering discontinuation of doxepin drugs during pregnancy and the postpartum period.

Fetal/Neonatal Adverse Reactions Neonates previously exposed to TCAs, including doxepin hydrochloride capsules, late in the third trimester during pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. 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 direct toxic effects of TCAs or possibly a drug discontinuation syndrome. Monitor neonates who were exposed to doxepin hydrochloride capsules in the third trimester of pregnancy for poor neonatal adaptation syndrome. Data Human Data Published epidemiological studies of pregnant women exposed to TCAs, including doxepin hydrochloride capsules, have not established an association with major birth defects, miscarriage, or adverse maternal outcomes.

Methodological limitations of these observational studies include small sample size and lack of adequate controls.

8.2Lactation Risk Summary Data from published literature report the presence of doxepin and nordoxepin in human milk. There are reports of excessive sedation, respiratory depression, poor suckling and swallowing and hypotonia in…

🤰 Pregnancy ~2 min read ▾

Methodological limitations of these observational studies include small sample size and lack of adequate controls.

🧒 Pediatric Use 37 words ▾

8.4Pediatric Use The safety and effectiveness of doxepin hydrochloride capsules in pediatric patients have not been established. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Warnings and Precautions (5.1) ] .

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use Clinical studies of doxepin did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Sedating drugs, including doxepin hydrochloride capsules, may cause confusion and oversedation in geriatric patients. The recommended starting doxepin hydrochloride capsules dosage in geriatric patients is generally lower than those of younger adult patients .

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE Signs, Symptoms, and Complications of Doxepin Hydrochloride Capsules Overdose Serious manifestations of tricyclic antidepressant (TCA) overdose include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Deaths may occur from overdosage with TCAs, including doxepin hydrochloride capsules. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of TCA toxicity.

A maximal limb-lead QRS duration of ≥ 0.1 seconds may be the best indication of the TCA overdose severity. Signs and symptoms of TCA toxicity develop rapidly after TCA overdose. Other signs of TCA overdose may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, or hyperpyrexia.

There are reports of patients succumbing to fatal dysrhythmia late after TCA overdose. Management of Overdose The following are recommendations for the management of a doxepin hydrochloride capsules overdose. Contact the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

With a doxepin hydrochloride capsules overdose, obtain an ECG and immediately initiate cardiac monitoring in the hospital. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS depression, respiratory depression, hypotension, cardiac dysrhythmias, conduction blocks, and seizures is recommended. If signs of toxicity occur during this period, extended monitoring is recommended.

Monitoring of plasma doxepin levels should not guide doxepin hydrochloride capsules overdose management. Cardiovascular Toxicity Management: Intravenous sodium bicarbonate should be administered to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate to intravenous sodium bicarbonate therapy, hyperventilation may also be used.

With concomitant use of hyperventilation and sodium bicarbonate therapy frequently monitor pH and pCO2. A pH > 7.6 or a pCO2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to intravenous sodium bicarbonate therapy/hyperventilation may respond to lidocaine therapy.

Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide) in the setting of TCA overdose. Hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in TCA overdose due to high tissue and protein binding of doxepin. CNS Toxicity Management: In patients with TCA overdose who have CNS depression, early intubation is recommended because of the potential for abrupt deterioration.

Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, propofol). Avoid use of physostigmine to treat TCA overdose.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of the doxepin hydrochloride capsules in the treatment of MDD in adult patients is not well understood.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of doxepin have not been fully characterized.

12.3Pharmacokinetics Absorption In healthy volunteers, a single oral doxepin hydrochloride capsule dose of 75 mg resulted in peak plasma doxepin concentrations that ranged from 8.8 ng/mL to 45.8 ng/mL (mean 26.1 ng/mL). Peak levels were reached between 2 and 4 hours (mean 2.9 hours) after doxepin hydrochloride capsules administration. Peak levels for the primary active metabolite N-desmethyldoxepin (nordoxepin) ranged from 4.8 ng/mL to 14.5 ng/mL (mean 9.7 ng/mL) and were achieved between 2 and 10 hours after doxepin hydrochloride capsules administration.

Distribution The mean apparent volume of distribution for doxepin was approximately 20 L/kg. The protein binding for doxepin was approximately 76%. Elimination In healthy volunteers, the plasma elimination half-life of doxepin ranged from 8 to 24 hours (mean 17 hours).

The half-life of nordoxepin ranged from 33 to 80 hours (mean 51 hours). The mean plasma clearance for doxepin was approximately

0.84L/hour/kg. Metabolism After oral doxepin administration, approximately 55% to 87% of doxepin undergoes first-pass metabolism in the liver, forming the primary active metabolite nordoxepin. Metabolic pathways of doxepin include demethylation, N-oxidation, hydroxylation and glucuronide formation.

Excretion Doxepin is excreted primarily in the urine, mainly as its metabolites, either free or in conjugate form. Specific Populations Patients with Hepatic Impairment Specific clinical studies have not been performed to evaluate the pharmacokinetics of doxepin in patients with hepatic impairment. Patients with hepatic impairment may have a greater systemic doxepin exposure than those with normal liver function [see Use in Specific Populations (8.6) ].

Patients with Renal Impairment The extent of renal excretion of doxepin is unknown. Specific clinical studies have not been performed to evaluate the pharmacokinetics of doxepin in patients with renal impairment compared to those with normal renal function. Drug Interaction Studies Carbamazepine After concomitant use of doxepin and carbamazepine, the combined exposure of doxepin and nordoxepin (12 hours after the last dose) was decreased by 55% compared to that after the use of doxepin alone [see Drug Interactions (7) ].

Strong CYP2D6 Inhibitors CYP2D6 contributes to the metabolism of doxepin and concomitant use of doxepin with strong CYP2D6 inhibitors may increase doxepin exposure [see Drug Interactions (7) ]. Cimetidine Cimetidine is a non-specific inhibitor of CYP1A2, 2C19, 2D6, and 3A4. When cimetidine 300 mg twice daily was administered concomitantly with a single 6 mg dose of another oral doxepin product, there was approximately a 2-fold increase in doxepin C max and AUC compared to doxepin without cimetidine [see Drug Interactions (7) ] .

CYP2D6 Substrates: Concomitant use of doxepin and other CYP2D6 substrates may have impact on the plasma doxepin concentrations. The clinical significance of this possible impact is unknown.

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action The mechanism of action of the doxepin hydrochloride capsules in the treatment of MDD in adult patients is not well understood.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxepin Hydrochloride Capsules, USP are available containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, or 100 mg of doxepin. The 10 mg capsules are hard-shell, gelatin capsules with a buff opaque cap and buff opaque body axially printed with MYLAN over 1049 in black ink on both the cap and the body. They are available as follows: NDC 48433-035-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).

The 25 mg capsules are hard-shell, gelatin capsules with an ivory opaque cap and white opaque body axially printed with MYLAN over 3125 in black ink on both the cap and the body. They are available as follows: NDC 48433-036-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). The 50 mg capsules are hard-shell, gelatin capsules with an ivory opaque cap and ivory opaque body axially printed with MYLAN over 4250 in black ink on both the cap and the body.

They are available as follows: NDC 48433-037-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). The 100 mg capsules are hard-shell, gelatin capsules with a brite lite green opaque cap and white opaque body axially printed with MYLAN over 6410 in black ink on both the cap and the body. They are available as follows: NDC 48433-038-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.

📋 Description ~1 min read ▾

11 DESCRIPTION Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C 19 H 21 NO • HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride.

Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b , e ]oxepin-11(6 H )ylidene- N , N -dimethyl-, hydrochloride. The structural formula of doxepin is shown below.

Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate.

The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No.

6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No.

10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No.

40 Aluminum Lake, propylene glycol and shellac glaze. Doxepin Hydrochloride Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during doxepin hydrochloride capsules treatment and when the dosage is increased or decreased, and instruct them to report suicidal thinking and behavior to their health care provider [see Warnings and Precautions (5.1) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome particularly with the concomitant use of doxepin hydrochloride capsules and other serotonergic drugs (e.g., other TCAs, SSRIs, SNRIs, triptans, opioids), lithium, tryptophan, buspirone, and St.

John’s Wort and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid) [see Warnings and Precautions (5.2) , Drug Interactions (7) ]. Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Angle-Closure Glaucoma Advise patients that taking doxepin hydrochloride capsules can cause pupillary dilation, which in susceptible individuals, can trigger angle closure glaucoma.

Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.3) ] . Effects on Driving and Operating Heavy Machinery Inform patients that doxepin hydrochloride capsules can cause sedation and caution them against driving a car or operating dangerous machinery while taking doxepin hydrochloride capsules [see Warnings and Precautions (5.4) ] . Activation of Mania or Hypomania Advise patients to observe for signs of mania/hypomania activation and instruct them to report such symptoms to the healthcare provider.

Drug Interactions Inform patients that the use of doxepin hydrochloride capsules and certain other drugs increases the risk of doxepin hydrochloride capsule-associated adverse reactions or alternatively lower doxepin hydrochloride capsules effectiveness. Instruct patients to inform their healthcare provider about all the drugs that they are taking before taking doxepin hydrochloride capsules. Alcohol Use Advise patients to avoid the use of alcohol while taking doxepin hydrochloride capsules [see Drug Interactions (7) ].

Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to doxepin hydrochloride capsules during pregnancy. Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during doxepin hydrochloride capsules treatment. Advise pregnant women that doxepin hydrochloride capsules use late in pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support, or tube feeding [see Use in Specific Populations (8.1) ].

Lactation Advise patients that breastfeeding is not recommended during doxepin hydrochloride capsules treatment [see Use in Specific Populations (8.2) ] .

💬 Medication Guide ~3 min read ▾

Medication Guide Doxepin Hydrochloride Capsules, USP (dox' e pin hye" droe klor' ide) for oral use What is the most important information I should know about doxepin hydrochloride capsules? Doxepin hydrochloride capsules can cause serious side effects, including: Increased risk of suicidal thoughts and actions. Doxepin hydrochloride capsules and other antidepressant medicines may 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.

Doxepin hydrochloride capsules are not for use in children. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behavior, 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. Call your health care 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 health care provider as scheduled.

Call your health care provider between visits as needed, especially if you have concerns about symptoms. Call your health care provider or get emergency help right away if you or a family member 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 doxepin hydrochloride capsules?” for more information about side effects.

What are doxepin hydrochloride capsules? Doxepin hydrochloride capsules are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). It is not known if doxepin hydrochloride capsules are safe and effective for use in children.

Do not take doxepin hydrochloride capsules if you: are allergic to doxepin, or any of the ingredients in doxepin hydrochloride capsules. See the end of this Medication Guide for a complete list of ingredients in doxepin hydrochloride capsules have glaucoma have or have had trouble urinating 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 health care provider or pharmacist if you are not sure if you are taking an MAOI, including the antibiotic linezolid or intravenous methylene blue Do not start taking an MAOI for at least 14 days after you stop treatment with doxepin hydrochloride capsules Before taking doxepin hydrochloride capsules, tell your health care provider about all your medical conditions, including if you: have, or have a family history of bipolar disorder, mania, or hypomania have or had depression, suicidal thoughts or behavior have kidney or liver problems have or had seizures or convulsions are pregnant or plan to become pregnant.

Taking doxepin hydrochloride capsules during your third trimester of pregnancy may harm your unborn baby. Tell your health care provider if you become pregnant or think you may be pregnant during treatment with doxepin hydrochloride capsules Babies born to mothers who take certain medicines, including doxepin hydrochloride capsules, during the third trimester of pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, low muscle tone, feeding problems, and withdrawal symptoms. Talk to your health care provider about the risks to your unborn or newborn baby if you take doxepin hydrochloride capsules during pregnancy There is a pregnanc…

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

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

exacerbation: A flare-up or worsening of a condition.

sedative: A substance with a calming effect that can also cause drowsiness.

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.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

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.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alopecia: Loss of hair from the scalp or body.

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

apnea: A pause or temporary stop in breathing.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

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

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.

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.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

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.

convulsion: Uncontrolled, rapid shaking of the body caused by muscles rapidly tightening and relaxing, often during a seizure.

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.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

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

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

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 Abuse and Dependence: A label section describing a medicine's potential to be misused and to cause the body to rely on 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.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

dyskinesia: Involuntary, uncontrolled movements of the face, arms, legs, or body.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

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

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

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.

first-pass metabolism: The breakdown of a swallowed medicine by the liver before it reaches the rest of the body.

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.

galactorrhea: Milky discharge from the breasts that is not related to breastfeeding.

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

gynecomastia: Swelling or enlargement of breast tissue in males.

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

hallucination: Seeing, hearing, feeling, or smelling something that is not actually there.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

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

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.

hypoesthesia: A reduced sense of touch or feeling in part of the body, so it feels partly numb.

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.

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.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

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.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

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.

mydriasis: Widening of the pupil, the dark center of the eye.

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.

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

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

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.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

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.

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.

pruritus: Itching of the skin.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

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

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

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

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

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

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

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

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

tardive dyskinesia: Involuntary, repetitive movements—often of the face, mouth, or tongue—that can develop after long-term use of certain medicines.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

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.

urticaria: Raised, itchy welts on the skin, commonly called hives.

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.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 48433-0034-08 · Safecor 48433-0036-20 · Safecor →

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.

Doxepin Hydrochloride 10 mg Capsule, 100-count

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