Back to search

United States· US:27241-170_4f6891be-49a9-4884-a1ce-35e148c7c156

Doxepin hydrochloride

A doxepin product containing doxepin hydrochloride, registered in United States by Ajanta Pharma USA Inc.. The same ATC class is registered in 2 of our 19 countries.

ATC D04AX01Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDoxepin hydrochlorideATCD04AX01REGISTER NO.US:27241-170_4f6891be…PACKS LISTED2CHECKEDSeptember 12, 2026

Where it is registered

Doxepin is registered in 2 of 19 countries.

Countries holding a registration under ATC D04AX01 (doxepin), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 1 of them publish a price we can compare per daily dose

Doxepin · ATC D04AX01

2 / 19 countries

  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Doxepin hydrochloride
Manufacturer
Ajanta Pharma USA Inc.
Country
United States (US)
ATC code
D04AX01
ATC class
Doxepin
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    2724117001
    100 CAPSULE in 1 BOTTLE (27241-170-01)
  • ndc11
    2724117010
    1000 CAPSULE in 1 BOTTLE (27241-170-10)

Regulatory notes

UNII (FDA substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A212624
ABABABABAB
DailyMed SPL labels
1 version tracked

Interactions

591 interactions on record for doxepin.

Graded by severity as the source publishes them — 127 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Doxepin · interactions on record

591 records

  • 127 severe
  • 448 moderate
  • 16 minor

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • OndansetronA04AA01severe
  • GranisetronA04AA02severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Doxepin in 4 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All doxepin products

Authorised across Europe · EMA

The same active substance is authorised in 5 EEA countries. Names it is sold under:

  • Germany · Aponal Ampullen, Aponal Tropfen
  • France · Quitaxon
  • United Kingdom (Northern Ireland) · Doxepin Zentiva Pharma, Xepin
  • Poland · Doxepin Teva
  • Romania · Doxepin Terapia

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/f0c02dc8-b2c4-4bad-a0e4-ba492e5ef299
GET /v1/drugs/f0c02dc8-b2c4-4bad-a0e4-ba492e5ef299?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "3U9A0FE9N5",
    "rxcui": "203179",
    "inchikey": null,
    "display_name": "DOXEPIN HYDROCHLORIDE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "spl_meta": {
    "89ed6385-cf6a-458e-81ea-c7f3fead41c5": {
      "match": "brand_token",
      "title": "DOXEPIN HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "27241-170_4f6891be-49a9-4884-a1ce-35e148c7c156",
  "productndc": "27241-170",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212624",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Sep 13, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Sep 13, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Sep 13, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "004",
        "approval_date": "Sep 13, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "005",
        "approval_date": "Sep 13, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXEPIN HYDROCHLORIDE",
  "proprietary_name": "Doxepin hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212624",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxepin hydrochloride",
  "start_marketing_date": "20191220",
  "active_numerator_strength": "75"
}

See everything about doxepin.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.