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Doxepin Hydrochloride 10 mg Capsule, 100-count — NDC 62332-0637-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doxepin Hydrochloride 10 mg Capsule, 100-count — NDC 62332-637-31 (Billing 62332-0637-31)

by Alembic Pharmaceuticals Inc. · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Doxepin Hydrochloride 10 mg Capsule from Alembic Pharmaceuticals Inc., marketed since Apr 2021 and currently FDA-listed; retail pharmacies pay about $0.0779 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 62332-0637-31
🏷️ FDA NDC (as labeled) 62332-637-31 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0779 NADAC Per package$7.79 / 100 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3059/unit · Part D plans $0.4302/unit — full pricing hub ↓
Main listing for product 62332-637 · Also comes in: 1000 capsules 62332-637-91
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

🚨
Active recall for this product.
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
Lots / codes: Lot: 2305015142, Exp. Date: 9/30/2025 · reported Aug 13, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62332-637-31
Product NDC 62332-637
11-digit billing NDC 62332063731
NCPDP billing unit EA — each (per item)
RxCUI 1000048, 1000058, 1000070, 1000076, 1000097
UNII 3U9A0FE9N5
UPC 0362332645312
Application # ANDA215076
SPL Set ID 4920401a-cde5-404b-82aa-c3c0e8911065
Established class (EPC) Tricyclic Antidepressant
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-23
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 58200040100105
GPI class Doxepin HCl
GCN Seq No 046086
GCN 16563
HICL code 001650
Ingredient (HICL) Doxepin Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2U
Therapeutic class — specific (HIC3) Tricyclic Antidepressants,Rel.non-Sel.reupt-Inhib
AHFS code 28:16.04.28
AHFS class Tricyclics, Other Norepi-Ru Inhibitors
FDB label name DOXEPIN 10 MG CAPSULE
FDB brand name Doxepin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 046086
  • GCN: 16563
  • GPI-14 (Medi-Span): 58200040100105
  • HICL (First Databank): 001650
  • AHFS class code: 28:16.04.28
  • RxCUI (RxNorm): 1000048
Why two NDCs? The FDA registers this code as 62332-637-31 — 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 → 62332-0637-31. 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 10 MG CAPSULE Ingredient Doxepin Hcl
📗 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 $0.078 $7.79 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.3059 $30.59 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.4302 $43.02 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.232 $0.078
▼ Down 66% over the last 24 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 Per unit Per pack Marketing startMarketing endStatus
62332-0637-31 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE $0.0779 / ea $7.79 2021-04-23 — Active
62332-0637-91 62332-637-91 1000 CAPSULE in 1 BOTTLE — — 2021-04-23 — Active

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

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

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 62332-0637-91?
Both are Doxepin Hydrochloride 10 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 62332-0637-91 is the 1000 capsules package.
What NDC number is used to bill for this package of Doxepin Hydrochloride 10 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxepin Hydrochloride 10 mg 42806-0529-01 Epic 100 capsules $0.078 AB Availability likely +0%
Doxepin Hydrochloride 10 mg 71921-0162-01 Florida 100 capsules $0.078 AB Availability likely +0%
Doxepin Hydrochloride 10 mg 00378-1049-01 Mylan 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 00904-7052-61 Major 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 23155-0794-01 Heritage 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 24658-0793-01 PURACAP 100 capsules $0.078 AB Availability likely —
Doxepin hydrochloride 10 mg 27241-0167-01 Ajanta 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 51079-0436-20 Mylan 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 59651-0173-01 Aurobindo 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 62135-0560-90 Chartwell 90 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mgthis 62332-0637-31 Alembic 100 capsules $0.078 AB Availability likely —
Doxepin hydrochloride 10 mg 64980-0594-01 Rising 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 70756-0424-11 Lifestar 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 72205-0088-91 Novadoz 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 72603-0390-01 NorthStar 100 capsules $0.078 AB Availability likely —
Doxepin Hydrochloride 10 mg 69315-0158-01 Leading 100 capsules $0.100 AB FDA listed +28%
Doxepin Hydrochloride 10 mg 69238-1166-01 Amneal 1000 capsules $0.208 AB FDA listed +167%
Doxepin Hydrochloride 10 mg 10267-5059-04 Contract 1000 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 42571-0420-01 Micro 100 capsules — AB Discontinued —
Doxepin Hydrochloride 10 mg 43353-0329-09 Aphena 9000 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 46708-0637-31 Alembic 100 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 48433-0035-20 Safecor 100 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 55801-0527-01 Appco 100 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 67296-2165-02 Redpharm 20 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 68071-5179-09 NuCare 90 capsules — AB FDA listed —
Doxepin hydrochloride 10 mg 70518-3594-00 REMEDYREPACK 30 capsules — AB Discontinued —
Doxepin Hydrochloride 10 mg 70518-4252-00 REMEDYREPACK 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 71205-0534-30 Proficient 30 capsules — AB FDA listed —
Doxepin hydrochloride 10 mg 71205-0695-30 Proficient 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 71335-0072-01 Bryant 30 capsules — AB FDA listed —
Doxepin hydrochloride 10 mg 71335-2092-01 Bryant 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 71335-2452-01 Bryant 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 71335-2647-01 Bryant 30 capsules — AB FDA listed —
Doxepin HCL 10 mg 72189-0355-30 Direct_Rx 30 capsules — — FDA listed —
Doxepin HCL 10 mg 72189-0574-30 Direct_rx 30 capsules — AB FDA listed —
Doxepin HCL 10 mg 72189-0590-30 Direct_rx 30 capsules — AB FDA listed —
Doxepin HCL 10 mg 72189-0633-30 Direct_Rx 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 72789-0072-30 PD-Rx 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 72789-0220-30 PD-Rx 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 81469-0415-01 First 100 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 83209-0424-30 Boswell 30 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 50090-8009-00 A-S 90 capsules — AB FDA listed —
Doxepin Hydrochloride 10 mg 82804-0305-30 Proficient 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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 / White / Green
ShapeCapsule
ImprintA344
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA215076 (ANDA)
Labeler code62332
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio492 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 💬 Medication Guide 🧬 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 119 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 capsule is 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 capsule is not approved for use in pediatric patients ( 8.4 )

🎯 Indications and Usage 41 words ▾

1 INDICATIONS AND USAGE Doxepin hydrochloride capsule is indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsule is 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 (4.4), Warnings and Precautions (5.2), and Drug Interactions (7)].

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

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

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

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

💊 Dosage Forms and Strengths 210 words ▾

3 DOSAGE FORMS AND STRENGTHS 10 mg are buff opaque cap/buff opaque body size ‘4’ hard gelatin capsule shell axially imprinted with ‘A 340’ on cap in black ink and filled with white to off white granular powder. 25 mg are ivory opaque cap/white opaque body size ‘3’ hard gelatin capsule shell axially imprinted with ‘A 341’ on cap in black ink and filled with white to off white granular powder. 50 mg are ivory opaque cap/ivory opaque body size ‘3’ hard gelatin capsule shell axially imprinted with ‘A 342’ on cap in black ink and filled with white to off white granular powder.

75 mg are brite lite green opaque cap/brite lite green opaque body size ‘2’ hard gelatin capsule shell axially imprinted with ‘A 343’ on cap in black ink and filled with white to off white granular powder. 100 mg are brite lite green opaque cap/white opaque body size ‘1’ hard gelatin capsule shell axially imprinted with ‘A 344’ on cap in black ink and filled with white to off white granular 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 115 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 < 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 concomitant use of other serotonergic drugs (e.g., other tricyclic antidepressants, SSRIs, serotonin norepinephrine reuptake inhibitors, triptans, tetracyclic antidepressants, opioids), lithium, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (e.g., MAOIs intended to treat psychiatric disorders and others, such as linezolid or intravenous methylene blue) [see Drug Interactions (7)] .

Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitati… [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 Alembic Pharmaceuticals Limited at 1-866-210-9797 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 [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 : Concomitant us… [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-research programs/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-research programs/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 35 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 pCO2. A pH > 7.6 or a pCO2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to intravenous sodium bicarbonate therapy/hyperventilation may respond to lidocaine therapy.

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

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

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of the doxepin hydrochloride 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 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 159 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied See Table 3 for strengths and package configurations for doxepin hydrochloride capsules, USP. Table 3: Doxepin Hydrochloride Capsules, USP Strengths and Package Configurations Strength* Capsule Cap and Body Color Capsule Imprinting in Black Bottle Count NDC 10 mg Buff opaque cap and buff opaque body A 340 100 $ 62332-637-31 1000 62332-637-91 25 mg Ivory opaque cap and white opaque body A 341 100 $ 62332-638-31 1000 62332-638-91 50 mg Ivory opaque cap and ivory opaque body A 342 100 $ 62332-645-31 1000 62332-645-91 75 mg Brite lite green opaque cap and brite lite green opaque body A 343 100 $ 62332-639-31 1000 62332-639-91 100 mg Brite lite green opaque cap and white opaque body A 344 100 $ 62332-640-31 1000 62332-640-91 * Strength of doxepin $ With child resistant closure Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light.

📋 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 or almost white crystalline powder.

It is freely soluble in water, in alcohol and in methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b , e ]oxepin-11(6 H )ylidene- N , N -dimethyl-, hydrochloride.

The structural formula of doxepin is shown below. Doxepin Hydrochloride 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 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg and 113.05 mg of doxepin hydrochloride, respectively).

Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The capsule shell contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 75 mg and 100 mg capsule shell also contains FD&C Blue 1.

The capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac. FDA approved dissolution method differs from the USP dissolution method. structure

💬 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 (7.5)].

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: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 07/2025

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Doxepin Hydrochloride, USP (dox’ e pin hye” droe klor’ ide) What is the most important information I should know about doxepin hydrochloride capsules? Doxepin hydrochloride capsules can cause serious side effects, including: Increased risk of suicidal thoughts and actions. Doxepin hydrochloride capsules and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

Doxepin hydrochloride capsule is not for use in children. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.

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

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

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

Do not take doxepin hydrochloride capsules if you: are allergic to doxepin, or any of the ingredients in doxepin hydrochloride capsules. See the end of this Medication Guide for a complete list of ingredients in doxepin hydrochloride capsules have glaucoma have or have had trouble urinating are taking, or have stopped taking within the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue o Ask your health care provider or pharmacist if you are not sure if you are taking an MAOI, including the antibiotic linezolid or intravenous methylene blue o Do not start taking an MAOI for at least 14 days after you stop treatment with doxepin hydrochloride capsules.

Before taking doxepin hydrochloride capsules, tell your health care provider about all your medical conditions, including if you: have, or have a family history of bipolar disorder, mania, or hypomania have or had depression, suicidal thoughts or behavior have kidney or liver problems have or had seizures or convulsions are pregnant or plan to become pregnant. Taking doxepin hydrochloride capsules during your third trimester of pregnancy may harm your unborn baby. Tell your health care provider if you become pregnant or think you may be pregnant during treatment with doxepin hydrochloride capsules. o Babies born to mothers who take certain medicines, including doxepin hydrochloride capsules, during the third trimester of pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, low muscle tone, feeding problems, and withdrawal symptoms.

Talk to your health care provider about the risks to your unborn or newborn baby if you take doxepin hydrochloride capsules during pregnancy. o There is a p… [Excerpted — this section continues on DailyMed.]

🧬 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 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 84 words ▾

9 DRUG ABUSE AND DEPENDENCE

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

9.2Abuse Doxepin hydrochloride is 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 after prolonged administration can result in withdrawal symptoms, which is indicative of physical dependence.

🔒 Controlled Substance 13 words ▾

9.1Controlled Substance Doxepin hydrochloride 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 15 words ▾

Dosage and Administration (2.4, 2.5, 2.6, 2.7, 2.8) 7/2025 Warnings and Precautions (5.2, 5.5) 7/2025

📄 Package Label / Principal Display Panel 149 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg NDC 62332-637-31 Doxepin Hydrochloride Capsules, USP 10 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Capsules Alembic 100 capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg NDC 62332-638-31 Doxepin Hydrochloride Capsules, USP 25 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Capsules Alembic 100 capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 50 mg NDC 62332-645-31 Doxepin Hydrochloride Capsules, USP 50 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Capsules Alembic doxepin-50-mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75 mg NDC 62332-639-31 Doxepin Hydrochloride Capsules, USP 75 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Capsules Alembic 100 capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 mg NDC 62332-640-31 Doxepin Hydrochloride Capsules, USP 100 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 100 Capsules Alembic 100 capsules

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
27.2K
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$320.3K
Avg / prescription
$11.75
Avg / unit
$0.3059
Latest quarter Q4 2025
3.3KRx
Medicaid pays / ea
$0.3059
gross reimbursed
vs
NADAC / ea
$0.0779
acquisition cost
=
Spread
+$0.2280
+293% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 11,302 Rx Managed care · 15,943 Rx
State Medicaid map
Alaska: no data reported AK Maine: 5,392 units · 387 per 100k residents ME Washington: 33,829 units · 433 per 100k residents WA Idaho: 9,721 units · 495 per 100k residents ID Montana: 7,924 units · 700 per 100k residents MT North Dakota: 5,695 units · 727 per 100k residents ND Minnesota: 34,014 units · 593 per 100k residents MN Wisconsin: 16,292 units · 276 per 100k residents WI Michigan: 38,482 units · 383 per 100k residents MI New York: 68,776 units · 351 per 100k residents NY Vermont: 5,458 units · 844 per 100k residents VT New Hampshire: 4,009 units · 286 per 100k residents NH Oregon: 27,776 units · 656 per 100k residents OR Nevada: 6,262 units · 196 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,657 units · 180 per 100k residents SD Iowa: 10,285 units · 321 per 100k residents IA Illinois: 24,080 units · 192 per 100k residents IL Indiana: 21,892 units · 319 per 100k residents IN Ohio: 91,860 units · 779 per 100k residents OH Pennsylvania: 56,608 units · 437 per 100k residents PA New Jersey: 19,083 units · 205 per 100k residents NJ Massachusetts: 14,575 units · 208 per 100k residents MA California: 53,862 units · 138 per 100k residents CA Utah: 9,887 units · 289 per 100k residents UT Colorado: 17,226 units · 293 per 100k residents CO Nebraska: 9,306 units · 470 per 100k residents NE Missouri: 54,342 units · 877 per 100k residents MO Kentucky: 32,662 units · 722 per 100k residents KY West Virginia: 15,526 units · 877 per 100k residents WV Virginia: 18,759 units · 215 per 100k residents VA Maryland: 17,911 units · 290 per 100k residents MD Connecticut: 11,585 units · 320 per 100k residents CT Rhode Island: 3,154 units · 288 per 100k residents RI Arizona: 35,917 units · 483 per 100k residents AZ New Mexico: 8,074 units · 382 per 100k residents NM Kansas: 2,364 units · 80.4 per 100k residents KS Arkansas: 5,110 units · 167 per 100k residents AR Tennessee: 21,933 units · 308 per 100k residents TN North Carolina: 50,468 units · 466 per 100k residents NC South Carolina: 3,205 units · 59.7 per 100k residents SC Delaware: 695 units · 67.4 per 100k residents DE Oklahoma: 10,595 units · 261 per 100k residents OK Louisiana: 34,790 units · 761 per 100k residents LA Mississippi: 2,040 units · 69.4 per 100k residents MS Alabama: 8,916 units · 175 per 100k residents AL Georgia: 11,979 units · 109 per 100k residents GA D.C.: 3,690 units · 543 per 100k residents DC Hawaii: no data reported HI Texas: 46,606 units · 153 per 100k residents TX Florida: 14,402 units · 63.7 per 100k residents FL
Units reimbursed · per 100k residents
59.7877
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 877 /100k
2 Missouri 877 /100k
3 Vermont 844 /100k
4 Ohio 779 /100k
5 Louisiana 761 /100k
6 North Dakota 727 /100k
7 Kentucky 722 /100k
8 Montana 700 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules this page62332-0637-31 27,245 Rx · $320,264
1000 capsules62332-0637-91 No Medicaid data
Drug total (last 4 qtrs): 27,245 Rx · 1,047,073 units · $320,264 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 62332-0636-06 · Alembic 62332-0638-31 · Alembic →
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.