Home › NDC Lookup › Ingredients › Doxepin Hydrochloride › 62135-0564-90
Doxepin Hydrochloride 100 mg Capsule, 90-count — NDC 62135-0564-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doxepin Hydrochloride 100 mg Capsule, 90-count — NDC 62135-564-90 (Billing 62135-0564-90)

by Chartwell RX, LLC · 90 CAPSULE in 1 BOTTLE

This is a package of 90 capsules of Doxepin Hydrochloride 100 mg Capsule from Chartwell RX, LLC, marketed since Sep 2020 and currently FDA-listed; retail pharmacies pay about $0.2901 per capsule (NADAC). It is this product's only package size.

NDC 62135-0564-90
🏷️ FDA NDC (as labeled) 62135-564-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-564-90
Product NDC 62135-564
11-digit billing NDC 62135056490
NCPDP billing unit EA — each (per item)
RxCUI 1000048, 1000058, 1000070, 1000076, 1000097
UNII 3U9A0FE9N5
UPC 0362135561901, 0362135562908, 0362135564902, 0362135560904 +1 more
Application # ANDA210268
SPL Set ID 33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3
Established class (EPC) Tricyclic Antidepressant
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-04
Route ORAL
Dosage form CAPSULE
Substance DOXEPIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 58200040100125
GCN Seq No 046087
GCN 16564
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 100 MG CAPSULE
FDB brand name Doxepin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 046087
  • GCN: 16564
  • GPI-14 (Medi-Span): 58200040100125
  • HICL (First Databank): 001650
  • AHFS class code: 28:16.04.28
  • RxCUI (RxNorm): 1000048
Why two NDCs? The FDA registers this code as 62135-564-90 — 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 → 62135-0564-90. 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

Label name DOXEPIN 100 MG CAPSULE Ingredient Doxepin Hcl
📖 What it is MedlinePlus · NLM

Doxepin is used to treat depression and anxiety. Doxepin is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed for mental balance. Doxepin is also available as a tablet to treat insomnia. This monograph only gives information about doxepin for depression or anxiety. If you are using this medication for insomnia, read the monograph entitled doxepin (insomnia).

Read the full MedlinePlus article ↗
📗 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 eaPer package
Retail pharmacies payNADAC · weekly $0.290 $26.11 / 90 capsules
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 $38.72 / 90 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.432 $0.246
▼ Down 33% over the last 13 months.
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
62135-0564-90 You're viewing this Main listing 90 CAPSULE in 1 BOTTLE Sample 2022-11-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxepin Hydrochloride 100 mg 42806-0533-01 Epic 100 capsules $0.267 AB Availability likely save 8%
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 mgthis 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 +12%
Doxepin Hydrochloride 100 mg 71921-0166-01 Florida 100 capsules $0.324 AB FDA listed +12%
Doxepin Hydrochloride 100 mg 10267-5063-04 Contract 1000 capsules — AB FDA listed —
Doxepin Hydrochloride 100 mg 42571-0424-01 Micro 100 capsules — — 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color yellow / green
ShapeCapsule
ImprintCE;72
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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 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.

15 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.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA210268 (ANDA)
Labeler code62135
First marketedSep 2020
Product typeHuman Prescription Drug
Portfolio521 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. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 184 words ▾

Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.

Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Doxepin is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients and PRECAUTIONS: Pediatric Use .)

🎯 Indications and Usage 134 words ▾

INDICATIONS AND USAGE Doxepin hydrochloride capsules are recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).

Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient.

Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.

⏱️ Dosage and Administration 191 words ▾

DOSAGE AND ADMINISTRATION For most patients with illness of mild to moderate severity, a starting daily dose of 75 mg is recommended. Dosage may subsequently be increased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75 mg/day to 150 mg/day.

In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary. Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day. In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice.

Some of these patients have been controlled on doses as low as 25 to 50 mg/day. The total daily dosage of doxepin (as hydrochloride) may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day.

This dose may be given at bedtime. The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment. Anti-anxiety effect is apparent before the antidepressant effect.

Optimal antidepressant effect may not be evident for two to three weeks.

⛔ Contraindications 48 words ▾

CONTRAINDICATIONS Doxepin is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind. Doxepin is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.

⚠️ Warnings 1 words ▾

WARNINGS

🤒 Adverse Reactions 37 words ▾

ADVERSE REACTIONS NOTE: Some of the adverse reactions noted below have not been specifically reported with doxepin use. However, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing doxepin hydrochloride.

🆘 Overdosage 66 words ▾

OVERDOSAGE Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.

Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.

🧬 Clinical Pharmacology 187 words ▾

CLINICAL PHARMACOLOGY The mechanism of action of doxepin hydrochloride is not definitely known. It is not a central nervous system stimulant nor a monoamine oxidase inhibitor. The current hypothesis is that the clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses so that deactivation of norepinephrine by reuptake into the nerve terminals is prevented.

Animal studies suggest that doxepin hydrochloride does not appreciably antagonize the antihypertensive action of guanethidine. In animal studies anticholinergic, antiserotonin and antihistamine effects on smooth muscle have been demonstrated. At higher than usual clinical doses, norepinephrine response was potentiated in animals.

This effect was not demonstrated in humans. At clinical dosages up to 150 mg per day, doxepin can be given to man concomitantly with guanethidine and related compounds without blocking the antihypertensive effect. At dosages above 150 mg per day blocking of the antihypertensive effect of these compounds has been reported.

Doxepin is virtually devoid of euphoria as a side effect. Characteristic of this type of compound, doxepin has not been demonstrated to produce the physical tolerance or psychological dependence associated with addictive compounds.

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

HOW SUPPLIED 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 capsule is a hard-shell, gelatin capsule with a yellow opaque cap and yellow opaque body. The capsules are imprinted with “CE” in black ink on the cap and “68” on the body.

They are available as follows: Bottles of 90 capsules (NDC 62135-560-90) The 25 mg capsule is a hard-shell, gelatin capsule with a light yellow opaque cap and white opaque body. The capsules are imprinted with "CE” in black ink on the cap and "69” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-561-90) The 50 mg capsule is a hard-shell, gelatin capsule with a light yellow opaque cap and light yellow opaque body.

The capsules are imprinted with “CE” in black ink on the cap and “70” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-562-90) The 75 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and light green opaque body. The capsules are imprinted with “CE” in black ink on the cap and "71” on the body.

They are available as follows: Bottles of 90 capsules (NDC 62135-563-90) The 100 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and a white opaque body. The capsules are imprinted with “CE” in black ink on the cap and “72” on the body. They are available as follows: Bottles of 90 capsules (NDC 62135-564-90) Store 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. Manufactured for Chartwell RX, LLC Congers, NY 10920 L70893 Revised 11/2022 Print Medication Guide at: www.chartwellpharma.com/medguides

📋 Description ~1 min read ▾

DESCRIPTION Doxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NO ∙ HCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform.

It may be represented by the following structural formula: Doxepin HCl Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b,e ]oxepin-11 (6 H )ylidene- N,N -dimethyl-,hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate.

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

6 and the 75 mg and 100 mg empty gelatin capsule shells contain yellow iron oxide and FD&C Blue No. 1. Black ink contains shellac glaze, isopropyl alcohol, black iron oxide, n-butyl alcohol, propylene glycol, and ammonium hydroxide. image description

⚠️ Precautions 1 words ▾

PRECAUTIONS

📄 Package Label / Principal Display Panel 74 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Doxepin Hydrochloride Capsules, USP 10mg - NDC 62135-560-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 25mg - NDC 62135-561-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 50mg - NDC 62135-562-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 75mg - NDC 62135-563-90 - 90's - Bottle-Label Doxepin Hydrochloride Capsules, USP 100mg - NDC 62135-564-90 - 90's - Bottle-Label image description image description image description image description image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62135-0563-90 · Chartwell 62135-0572-30 · Chartwell →
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.