Active substance
Doxepin
- US FDA 87
- Health Canada 26
- US price lines 10
- NHS prices 4
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | capsule · oral | MYLAN | Prescription | 13 May 1986 |
| DOXEPIN HYDROCHLORIDE | EQ 50MG BASE; EQ 10MG BASE; EQ 25MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | MYLAN PHARMS INC | Prescription | 13 May 1986 |
| DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | capsule · oral | MYLAN | Prescription | 13 May 1986 |
| DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | capsule · oral | MYLAN | Prescription | 13 May 1986 |
| DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | capsule · oral | PAR PHARM | Prescription | 9 Nov 1987 |
| ZONALON | 5% | cream · topical | MYLAN | Prescription | 1 Apr 1994 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE/ML | concentrate · oral | LANNETT CO INC | Prescription | 29 Dec 1998 |
| SILENOR | EQ 3MG BASE; EQ 6MG BASE | tablet · oral | CURRAX | Prescription | 17 Mar 2010 |
| DOXEPIN HYDROCHLORIDE | EQ 3MG BASE; EQ 6MG BASE | tablet · oral | ACTAVIS ELIZABETH | Prescription | 26 Jul 2013 |
| DOXEPIN HYDROCHLORIDE | EQ 3MG BASE; EQ 6MG BASE | tablet · oral | RK PHARMA | Prescription | 20 Jan 2016 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | AMNEAL PHARMS CO | Prescription | 28 Jun 2017 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | AUROBINDO PHARMA LTD | Prescription | 27 Mar 2019 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | AJANTA PHARMA LTD | Prescription | 13 Sep 2019 |
| DOXEPIN HYDROCHLORIDE | EQ 3MG BASE; EQ 6MG BASE | tablet · oral | STRIDES PHARMA INTL | Prescription | 24 Jul 2020 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | AIPING PHARM INC | Prescription | 28 Jul 2020 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | CHARTWELL RX | Prescription | 4 Sep 2020 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 100MG BASE; EQ 50MG BASE; EQ 75MG BASE | capsule · oral | EPIC PHARMA LLC | Prescription | 16 Oct 2020 |
| DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | capsule · oral | VELZEN PHARMA PVT | Prescription | 1 Mar 2021 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | LEADING | Prescription | 9 Mar 2021 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | APPCO | Prescription | 1 Apr 2021 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | ALEMBIC | Prescription | 21 Apr 2021 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | MANKIND PHARMA | Prescription | 9 Feb 2022 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | JUBILANT CADISTA | Prescription | 14 Mar 2022 |
| DOXEPIN HYDROCHLORIDE | EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | capsule · oral | MSN | Prescription | 24 Jun 2022 |
| DOXEPIN HYDROCHLORIDE | 5% | cream · topical | TEVA PHARMS | Prescription | 17 Feb 2023 |
62 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-DOXEPIN | 02049996 | 10 MG | CAPSULE · ORAL | APOTEX INC |
| APO-DOXEPIN | 02050005 | 25 MG | CAPSULE · ORAL | APOTEX INC |
| APO-DOXEPIN | 02050013 | 50 MG | CAPSULE · ORAL | APOTEX INC |
| APO-DOXEPIN | 02050021 | 75 MG | CAPSULE · ORAL | APOTEX INC |
| APO-DOXEPIN | 02050048 | 100 MG | CAPSULE · ORAL | APOTEX INC |
| JAMP DOXEPIN | 02559250 | 10 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP DOXEPIN | 02559269 | 25 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP DOXEPIN | 02559277 | 50 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP DOXEPIN | 02559285 | 75 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP DOXEPIN | 02559293 | 100 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP DOXEPIN TABLETS | 02551330 | 3 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP DOXEPIN TABLETS | 02551349 | 6 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MAR-DOXEPIN | 02559080 | 10 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-DOXEPIN | 02559099 | 25 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-DOXEPIN | 02559102 | 50 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-DOXEPIN | 02559110 | 75 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-DOXEPIN | 02559129 | 100 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| SILENOR | 02398257 | 3 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| SILENOR | 02398265 | 6 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| SINEQUAN | 00024325 | 10 MG | CAPSULE · ORAL | AA PHARMA INC |
| SINEQUAN | 00024333 | 25 MG | CAPSULE · ORAL | AA PHARMA INC |
| SINEQUAN | 00024341 | 50 MG | CAPSULE · ORAL | AA PHARMA INC |
| SINEQUAN | 00326925 | 100 MG | CAPSULE · ORAL | AA PHARMA INC |
| SINEQUAN | 00400750 | 75 MG | CAPSULE · ORAL | AA PHARMA INC |
| TARO-DOXEPIN | 02565102 | 3 MG | TABLET · ORAL | TARO PHARMACEUTICALS INC |
1 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DOXEPIN 10 MG CAPSULE | $0.07787 | per EA | 23 Sep 2026 |
| US NADAC | DOXEPIN 10 MG/ML ORAL CONC | $0.83884 | per ML | 23 Sep 2026 |
| US NADAC | DOXEPIN 100 MG CAPSULE | $0.29013 | per EA | 23 Sep 2026 |
| US NADAC | DOXEPIN 150 MG CAPSULE | $0.53643 | per EA | 23 Sep 2026 |
| US NADAC | DOXEPIN 25 MG CAPSULE | $0.14151 | per EA | 23 Sep 2026 |
| US NADAC | DOXEPIN 5% CREAM | $7.11754 | per GM | 23 Sep 2026 |
| US NADAC | DOXEPIN 50 MG CAPSULE | $0.15714 | per EA | 23 Sep 2026 |
| US NADAC | DOXEPIN 75 MG CAPSULE | $0.19659 | per EA | 23 Sep 2026 |
| US NADAC | DOXEPIN HCL 3 MG TABLET | $1.33336 | per EA | 23 Sep 2026 |
| US NADAC | DOXEPIN HCL 6 MG TABLET | $1.3716 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Doxepin 10mg capsules | £81.50 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Doxepin 25mg capsules | £2.65 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Doxepin 5% cream | £13.66 | 30 gram | 1 Oct 2026 |
| NHS Drug Tariff | Doxepin 50mg capsules | £3.05 | 28 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 3 Jul 2025 SINEQUAN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 3 Jul 2025 SINEQUAN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Oct 2020 SILENOR — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.