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Doxepin Hydrochloride 100 mg Capsule, 100-count — NDC 42571-424-01 (Billing 42571-0424-01)

by Micro Labs Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Doxepin Hydrochloride 100 mg Capsule from Micro Labs Limited, no longer marketed (first marketed Jan 2024), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 42571-0424-01
🏷️ FDA NDC (as labeled) 42571-424-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.4302/unit — full pricing hub ↓
Main listing for product 42571-424 · Also comes in: 1000 capsules 42571-424-13
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42571-424-01
Product NDC 42571-424
11-digit billing NDC 42571042401
RxCUI 1000048, 1000058, 1000070, 1000076, 1000097
UNII 3U9A0FE9N5
UPC 0342571424015, 0342571423018, 0342571420017, 0342571422011 +1 more
Application # ANDA217688
SPL Set ID 8a3ba1fd-de34-47e4-96ca-f3086aed4b76
Established class (EPC) Tricyclic Antidepressant
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2024-01-01
Route ORAL
Dosage form CAPSULE
Substance DOXEPIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1000048
Why two NDCs? The FDA registers this code as 42571-424-01 — 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 → 42571-0424-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Capsules treat depression and anxiety, the oral solution treats major depressive disorder in adults, tablets such as Silenor treat trouble staying asleep...
  • Take it within 30 minutes of bedtime. Do not take it within 3 hours of a meal. A meal can slow absorption and may cause more next-day effects.
  • Sleepiness is the most common, along with nausea, cold-like symptoms and dizziness. Dry mouth, blurred vision and constipation can also happen. Call me or your doctor if anything b...
  • Avoid it. Doxepin can make alcohol’s sedating effects stronger. Also avoid driving until you know how it affects you.
📖 Read our full Doxepin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 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.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4302 $43.02 / 100 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
42571-0424-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2024-01-01 — Discontinued by firm
42571-0424-13 42571-424-13 1000 CAPSULE in 1 BOTTLE 2024-01-01 — Discontinued by firm

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 42571-0424-13?
Both are Doxepin Hydrochloride 100 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 42571-0424-13 is the 1000 capsules package.
What NDC number is used to bill for this package of Doxepin Hydrochloride 100 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxepin Hydrochloride 100 mg 42806-0533-01 Epic 100 capsules $0.267 AB Availability likely —
Doxepin Hydrochloride 100 mg 00378-6410-01 Mylan 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 00904-7055-61 Major 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 23155-0798-01 Heritage 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 24658-0797-01 PURACAP 100 capsules $0.290 AB Availability likely —
Doxepin hydrochloride 100 mg 27241-0171-01 Ajanta 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 51079-0651-20 Mylan 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 59651-0177-01 Aurobindo 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 62135-0564-90 Chartwell 90 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 62332-0640-31 Alembic 100 capsules $0.290 AB Availability likely —
Doxepin hydrochloride 100 mg 64980-0598-01 Rising 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 70756-0428-11 Lifestar 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 72205-0092-91 Novadoz 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 72603-0394-01 NorthStar 100 capsules $0.290 AB Availability likely —
Doxepin Hydrochloride 100 mg 69315-0162-01 Leading 100 capsules $0.324 AB FDA listed —
Doxepin Hydrochloride 100 mg 71921-0166-01 Florida 100 capsules $0.324 AB FDA listed —
Doxepin Hydrochloride 100 mg 10267-5063-04 Contract 1000 capsules — AB FDA listed —
Doxepin Hydrochloride 100 mgthis 42571-0424-01 Micro 100 capsules — AB Discontinued —
Doxepin Hydrochloride 100 mg 46708-0640-31 Alembic 100 capsules — AB FDA listed —
Doxepin Hydrochloride 100 mg 48433-0038-20 Safecor 100 capsules — AB FDA listed —
Doxepin Hydrochloride 100 mg 55801-0531-01 Appco 100 capsules — AB FDA listed —
Doxepin Hydrochloride 100 mg 69238-1173-01 Amneal 1000 capsules — AB FDA listed —
Doxepin Hydrochloride 100 mg 70518-4179-00 REMEDYREPACK 30 capsules — AB FDA listed —
Doxepin Hydrochloride 100 mg 81469-0419-01 First 100 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerMicro Labs Limited
Application holderMICRO LABS LTD
FDA applicationANDA217688 (ANDA)
Labeler code42571
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio190 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 122 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 capsule is 25 mg three times daily or 75 mg once daily. The recommended target total oral dosage range for doxepin hydrochloride capsule 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 capsule 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 anticholinergiceffects (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 Reducethe 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 Reducethe doxepin hydrochloride capsules dosage based on doxepin plasma concentrations in patients who are known CYP2D6 and CYP2C19 poormetabolizers [see Use in Specific Populations (8.7) ].

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

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: Doxepin hydrochloride capsules USP, 10 mg: size “4” hard gelatin capsule with buff opaque cap and buff opaque body, imprinted “10” on cap with black ink and plain body filled with white to of white powder. Doxepin hydrochloride capsules USP, 25 mg: size "3" hard gelatin capsule with ivory opaque cap and white opaque body, imprinted "25" on cap with black ink and plain body filled with white to off white powder. Doxepin hydrochloride capsules USP, 50 mg: size "3" hard gelatin capsule with ivory opaque cap and ivory opaque body, imprinted "50" on cap with black ink and plain body filled with white to off white powder.

Doxepin hydrochloride capsules USP, 75 mg: size "2" hard gelatin capsule with brite lite green opaque cap and brite lite green opaque body, imprinted "75" on cap with black ink and plain body filled with white to off white powder. Doxepin hydrochloride capsules USP, 100 mg: size "1" hard gelatin capsule with brite lite green opaque cap and white opaque body, imprinted "100" on cap with black ink and plain body filled with white to off white powder. Active ingredients in the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, and 100 mg of doxepin.

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, 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 for the emergence of serotonin syndrome. Discontinue doxepin hydrochloride 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 in patients with untreated anatomically narrow angles.

( 5.3 ) Sedation and Driving Risks : Because doxepin hydrochloride can cause sedation, warn patients against driving a car or operating dangerous machinery while taking doxepin hydrochloride. ( 5.4 ) Activation of Mania or Hypomania : Prior to initiating antidepressant therapy, screen for bipolar disorder. doxepin hydrochloride is 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 is 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 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 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-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of doxepin hydrochloride 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, in patients who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome Tricyclic antidepressants,including doxepin hydrochloride, can precipitate serotonin syndrome, a potentially life-threatening condition. This risk is increased with concomitantuse 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 totreat psychiatric disorders and others, such as linezolid or intravenous methylene blue) [see Drug Interactions (7) ] .

Serotonin syndrome symptomsmay include mental status changes… [Excerpted — this section continues on DailyMed.]

🤒 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 Micro Labs USA, Inc. at 1-855-839-8195 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 hydrochloride-treated patients) in 1,635 doxepin hydrochloride-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 hydrochloride 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 hydrochloride. 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 hydrochloride [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 with other drugs or classes. Table 2: Clinically Significant Drug Interactions with Doxepin Hydrochloride Monoamine Oxidase Inhibitors Prevention or Management Doxepin hydrochloride is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue. The use of doxepin hydrochloride within 14 days of discontinuation of an MAOI or the use of MAOI within 14 days of discontinuation of doxepin hydrochloride is contraindicated.

Starting doxepin hydrochloride in a patient who is being treated with an MAOI is contraindicated. Clinical Effect(s) Concomitant use of doxepin hydrochloride and MAOIs increases the risk of serotonin syndrome [see 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 and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ]. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride 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 dosage or the strong CYP2D6 inhibitor as appropriate [see Dosage and Administration (2.5) ].

Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride with strong CYP2D6 inhibitors may increase the exposures of doxepin [see Clinical Pharmacology (12.3) ] which may increase the risk of doxepin hydrochloride 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 dosage in patients taking carbamazepine.

Mechanism and Clinical Effect(s) Concomitant use of carbamazepine with doxepin hydrochloride 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 dosage in patients taking cimetidine. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride with cimetidine may increase the exposures of doxepin [see Clinical Pharmacology (12.3) ] which may increase the risk of doxepin hydrochloride-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 may potentiate the sedative effects of alcohol [see Warnings and Precautions (5.4) ]. CNS Depressants Prevention or Management Dosage reduction of doxepin hydrochloride 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, 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 dosage as appropriate. Clinical Effect(s) Doxepin hydrochloride may cause severe hypoglycemia when concomitantly used with tolazamide.

Serotonergic Drugs : 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 and/or concomitant serotonergic drugs. ( 5.2 , 7 ) Strong CYP2D6 Inhibitors : C… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Neonates exposed to TCAs, including doxepin hydrochloride, 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 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-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, 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 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, 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 hydrochloride drugs during pregnancy and the postpartum period.

Fetal/Neonatal Adverse Reactions Neonates previously exposed to TCAs, including doxepin hydrochloride, 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 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, 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 breastfed infants exposed to doxepin at doses used to treat MDD. T… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including doxepin hydrochloride, 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 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, 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 hydrochloride drugs during pregnancy and the postpartum period.

Fetal/Neonatal Adverse Reactions Neonates previously exposed to TCAs, including doxepin hydrochloride, 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 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, 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.

🧒 Pediatric Use 36 words ▾

8.4Pediatric Use The safety and effectiveness of doxepin hydrochloride 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 63 words ▾

8.5Geriatric Use Clinical studies of doxepin hydrochloride 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, may cause confusion and oversedation in geriatric patients. The recommended starting doxepin hydrochloride 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 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. 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 overdose. Contact the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

With a doxepin hydrochloride 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 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 pCO 2 . A pH > 7.6 or a pCO 2 < 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 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 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 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 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 hydrochloride capsules 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 hydrochloride 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 hydrochloride alone [see Drug Interactions (7) ].

Strong CYP2D6 Inhibitors : CYP2D6 contributes to the metabolism of doxepin and concomitant use of doxepin hydrochloride 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 hydrochloride and other CYP2D6 substrates may have impact on the plasma doxepin concentrations. The clinical significance of this possible impact is unknown.

🧬 Mechanism of Action 24 words ▾

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

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxepin hydrochloride capsules, USP are available as capsules containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of doxepin. Doxepin hydrochloride capsules USP, 10 mg are supplied as size "4" hard gelatin capsule with buff opaque cap and buff opaque body, imprinted "10" on cap with black ink and plain body filled with white to off white powder. They are available as follows: Bottles of 100 with child-resistant closure: NDC 42571-420-01 Bottles of 1000: NDC 42571-420-13 Doxepin hydrochloride capsules USP, 25 mg are supplied as size "3" hard gelatin capsule with ivory opaque cap and white opaque body, imprinted "25" on cap with black ink and plain body filled with white to off white powder.

They are available as follows: Bottles of 100 with child-resistant closure: NDC 42571-421-01 Bottles of 1000: NDC 42571-421-13 Doxepin hydrochloride capsules USP, 50 mg are supplied as size "3" hard gelatin capsule with ivory opaque cap and ivory opaque body, imprinted "50" on cap with black ink and plain body filled with white to off white powder. They are available as follows: Bottles of 100 with child-resistant closure: NDC 42571-422-01 Bottles of 1000: NDC 42571-422-13 Doxepin hydrochloride capsules USP, 75 mg are supplied as size "2" hard gelatin capsule with brite lite green opaque cap and brite lite green opaque body, imprinted "75" on cap with black ink and plain body filled with white to off white powder.

They are available as follows: Bottles of 100 with child-resistant closure: NDC 42571-423-01 Bottles of 1000: NDC 42571-423-13 Doxepin hydrochloride capsules USP, 100 mg are supplied as size "1" hard gelatin capsule with brite lite green opaque cap and white opaque body, imprinted "100" on cap with black ink and plain body filled with white to off white powder. They are available as follows: Bottles of 100 with child-resistant closure: NDC 42571-424-01 Bottles of 1000: NDC 42571-424-13 Store doxepin hydrochloride capsules at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed.

📋 Description 197 words ▾

11 DESCRIPTION Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C 19 H 21 NO•HCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform.

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. It structural formula of doxepin is shown below.

Doxepin hydrochloride capsules, USP 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 11.30 mg, 28.26 mg, 56.52 mg, 84.78 mg, and 113.05 mg of doxepin hydrochloride, respectively). Inactive ingredients: magnesium stearate, pregelatinised starch, silicified microcrystalline cellulose and sodium lauryl sulfate.

The hard gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg capsule shells contains FD&C Yellow No. 5 and FD&C Red 40; and 75 mg and 100 mg capsules shells contains D&C Yellow 10 and FD&C Green 3.

The imprinting black ink contains black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 3. doxepin-stra.jpg

💬 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 capsules-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) ] . Manufactured by: Micro Labs Limited Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc.

Somerset, NJ 08873 Rev. 07/2025

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption In healthy volunteers, a single oral doxepin hydrochloride 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 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 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 hydrochloride capsules 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 hydrochloride 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 hydrochloride alone [see Drug Interactions (7) ].

Strong CYP2D6 Inhibitors : CYP2D6 contributes to the metabolism of doxepin and concomitant use of doxepin hydrochloride 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 hydrochloride and other CYP2D6 substrates may have impact on the plasma doxepin concentrations. The clinical significance of this possible impact is unknown.

🧬 Pharmacodynamics 23 words ▾

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

🔒 Drug Abuse and Dependence 87 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Doxepin hydrochloride capsules contains doxepin, which is not a controlled substance.

9.2Abuse Doxepin hydrochloride capsules are not associated with abuse.

9.3Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt cessation of doxepin hydrochloride capsules after prolonged administration can result in withdrawal symptoms, which is indicative of physical dependence.

🔒 Controlled Substance 14 words ▾

9.1Controlled Substance Doxepin hydrochloride capsules contains doxepin, which is not a controlled substance.

🧪 Nonclinical Toxicology 96 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of doxepin in animals has not been fully characterized. Mutagenesis The mutagenetic potential of doxepin in animals has not been fully characterized. Impairment of Fertility Doxepin had no effect on female fertility in rats at oral doses up to 25 mg/kg/day (1.6x the human dose of 150 mg/day on a mg/m 2 basis for a 60 kg human).

Insemination and conception were reduced in untreated female rats mated with male rats administered doxepin at 25 mg/kg/day for a period of ≥ 7 months.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 93 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of doxepin in animals has not been fully characterized. Mutagenesis The mutagenetic potential of doxepin in animals has not been fully characterized. Impairment of Fertility Doxepin had no effect on female fertility in rats at oral doses up to 25 mg/kg/day (1.6x the human dose of 150 mg/day on a mg/m 2 basis for a 60 kg human).

Insemination and conception were reduced in untreated female rats mated with male rats administered doxepin at 25 mg/kg/day for a period of ≥ 7 months.

📄 Recent Major Changes 22 words ▾

Dosage and Administration ( 2.4 , 2.5 , 2.6 , 2.7 ) 7/2025 Warnings and Precautions ( 5.2 , 5.5 ) 7/2025

📄 Package Label / Principal Display Panel 119 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-420-01 Doxepin Hydrochloride Capsules, USP 10 mg* Pharmacist: Dispense the accompanying Medication Guide to each patient. 100 Capsules Micro Labs Limited NDC 42571-421-01 Doxepin Hydrochloride Capsules, USP 25 mg* Pharmacist: Dispense the accompanying Medication Guide to each patient. 100 Capsules Micro Labs Limited NDC 42571-422-01 Doxepin Hydrochloride Capsules, USP 50 mg* Pharmacist: Dispense the accompanying Medication Guide to each patient.

100 Capsules Micro Labs Limited NDC 42571-423-01 Doxepin Hydrochloride Capsules, USP 75 mg* Pharmacist: Dispense the accompanying Medication Guide to each patient. 100 Capsules Micro Labs Limited NDC 42571-424-01 Doxepin Hydrochloride Capsules, USP 100 mg* Pharmacist: Dispense the accompanying Medication Guide to each patient. 100 Capsules Micro Labs Limited doxepin-figa.jpg doxepin-figb.jpg doxepin-figc.jpg doxepin-figd.jpg doxepin-fige.jpg

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

About this NDC listing & data coverage

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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.
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The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1000 capsules (42571-0424-13). Each has its own NDC and its own page — see the package list near the top of this page.
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Micro Labs Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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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.
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← 42571-0423-01 · Micro 42571-0427-01 · Micro →
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.