Doxepin Hydrochloride

Chartwell Rx, Llc
Human Prescription Drug
NDC 62135-561

Doxepin Hydrochloride is a human prescription drug labeled by 'Chartwell Rx, Llc'. National Drug Code (NDC) number for Doxepin Hydrochloride is 62135-561. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Doxepin Hydrochloride drug includes Doxepin Hydrochloride - 25 mg/1 . The currest status of Doxepin Hydrochloride drug is Active.

Drug Information:

Drug NDC:	62135-561
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Doxepin Hydrochloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Doxepin Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Chartwell Rx, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	DOXEPIN HYDROCHLORIDE - 25 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	04 Sep, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA210268
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Chartwell RX, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1000048 1000058 1000070 1000076 1000097
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0362135560904 0362135564902 0362135561901 0362135563905 0362135562908
UPC stands for Universal Product Code.
UNII:	3U9A0FE9N5
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Tricyclic Antidepressant [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
62135-561-90	90 CAPSULE in 1 BOTTLE (62135-561-90)	22 Nov, 2022	N/A	Yes
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Doxepin hydrochloride doxepin hydrochloride silicon dioxide magnesium stearate microcrystalline cellulose starch, corn sodium lauryl sulfate gelatin, unspecified titanium dioxide ferric oxide yellow shellac isopropyl alcohol ferrosoferric oxide butyl alcohol propylene glycol ammonia doxepin hydrochloride doxepin yellow cap and body ce;68 doxepin hydrochloride doxepin hydrochloride silicon dioxide magnesium stearate microcrystalline cellulose starch, corn sodium lauryl sulfate gelatin, unspecified titanium dioxide d&c yellow no. 10 fd&c yellow no. 6 shellac isopropyl alcohol ferrosoferric oxide butyl alcohol propylene glycol ammonia doxepin hydrochloride doxepin light yellow cap white body ce;69 doxepin hydrochloride doxepin hydrochloride silicon dioxide magnesium stearate microcrystalline cellulose starch, corn sodium lauryl sulfate gelatin, unspecified titanium dioxide d&c yellow no. 10 fd&c yellow no. 6 shellac isopropyl alcohol ferrosoferric oxide butyl alcohol propylene glycol ammonia doxepin hydrochloride doxepin light yellow cap and body ce;70 doxepin hydrochloride doxepin hydrochloride silicon dioxide magnesium stearate microcrystalline cellulose starch, corn sodium lauryl sulfate gelatin, unspecified titanium dioxide ferric oxide yellow fd&c blue no. 1 shellac isopropyl alcohol ferrosoferric oxide butyl alcohol propylene glycol ammonia doxepin hydrochloride doxepin light green cap and body ce;71 doxepin hydrochloride doxepin hydrochloride silicon dioxide magnesium stearate microcrystalline cellulose starch, corn sodium lauryl sulfate gelatin, unspecified titanium dioxide ferric oxide yellow fd&c blue no. 1 shellac isopropyl alcohol ferrosoferric oxide butyl alcohol propylene glycol ammonia doxepin hydrochloride doxepin light green cap and white body ce;72

Boxed Warning:

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:

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.

Warnings:

Warnings

Dosage and Administration:

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 th Read more...

erapy 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:

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.

Adverse Reactions:

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:

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.

Description:

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 â 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

Clinical Pharmacology:

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 anti Read more...

hypertensive 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:

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 âceâ in black ink on the cap and â68â 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 "ceâ in black ink on the cap and "69â 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 âceâ in black ink on the cap and â70â on the body. they are available as follows: bottles of 90 capsules (ndc 62135-562-90) t Read more...

he 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 âceâ in black ink on the cap and "71â 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 âceâ in black ink on the cap and â72â on the body. they are available as follows: bottles of 90 capsules (ndc 62135-564-90) store at 20Â° to 25Â°c (68Â° to 77Â°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

Package Label Principal Display Panel:

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

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.