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United States· US:53489-120_3309ec4b-fda9-8b52-e063-6394a90a5e18

Doxycycline Hyclate

A antiinfectives and antiseptics for local oral treatment product containing doxycycline hyclate, registered in United States by Sun Pharmaceutical Industries, Inc..

In shortageATC A01ABOrange 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…normalisedDoxycycline HyclateATCA01ABREGISTER NO.US:53489-120_3309ec4b…PACKS LISTED4CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about doxycycline hyclateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Doxycycline Hyclate
Manufacturer
Sun Pharmaceutical Industries, Inc.
Country
United States (US)
ATC code
A01AB
ATC class
Antiinfectives and antiseptics for local oral treatment
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 4

  • ndc11
    5348912001
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-01)
  • ndc11
    5348912002
    50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-02)
  • ndc11
    5348912005
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-05)
  • ndc11
    5348912060
    20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-60)

Regulatory notes

UNII (FDA substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A062677
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxycycline Hyclate Tablet

Same medicine, other countries

Doxycycline hyclate in 17 other countries

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

All doxycycline hyclate products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Doxybene, Doxycyclin G.L
  • Belgium · Doxycycline Eg, Doxycycline Sandoz
  • Bulgaria · Вибрамицин, Доксициклин Tzf
  • Cyprus · Doxat, Medomycin
  • Czechia · Deoxymykoin, Doxybene
  • Germany · Doxakne Tabs, Doxy
  • Denmark · Doxycycline Macure, Oracea
  • Estonia · Adoxtar, Doxy-M
  • Spain · Dosil, Doxiciclina Normon
  • Finland · Doximed, Doximycin
  • France · Doxy, Doxycycline Arrow
  • United Kingdom (Northern Ireland) · Doxycycline, Doxycycline Accord-Uk
  • Greece · Oracea, Smilitene
  • Croatia · Doksiciklin Belupo
  • Hungary · Doxitidin, Doxycyclin Al
  • Ireland · Doxycycline Activase Pharmaceuticals, Doxycycline Athlone Pharmaceuticals
  • Iceland · Doxycyklin Eql Pharma, Doxylin
  • Italy · Bassado, Doxynor
  • Liechtenstein · Ligosan
  • Lithuania · Adoxtar, Doxitin
  • Luxembourg · Doxycycline Eg, Doxycycline Sf Ratiopharm
  • Latvia · Doxitin, Doxy-M
  • Malta · Doxat, Doxycycline Activase
  • Netherlands · Doxycycline Accord, Doxycycline Disp Teva
  • Norway · Doksycyklin Hexal, Doxycycline Macure
  • Poland · Doxyclinum Tzf, Doxycycline
  • Portugal · Actidox, Adoxtar
  • Romania · Doxiciclină Arena, Doxiciclina Atb
  • Sweden · Doxycycline Macure, Doxycyklin Eql Pharma
  • Slovenia · Doksivibra
  • Slovakia · Deoxymykoin, Doxyhexal

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/04f15d28-3083-446a-a944-716df82b5673
GET /v1/drugs/04f15d28-3083-446a-a944-716df82b5673?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": "19XTS3T51U",
    "rxcui": "23663",
    "inchikey": "HALQELOKLVRWRI-VDBOFHIQSA-N",
    "display_name": "DOXYCYCLINE HYCLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 2
  },
  "spl_meta": {
    "52ba329a-8cb3-cf30-e063-6394a90aa0dc": {
      "match": "brand_token",
      "title": "DOXYCYCLINE HYCLATE CAPSULE [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "53489-120_3309ec4b-fda9-8b52-e063-6394a90a5e18",
  "productndc": "53489-120",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "062677",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Jul 10, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXYCYCLINE HYCLATE",
  "shortage_reason": "Doxycycline Hyclate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Doxycycline Hyclate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA062677",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline Hyclate",
  "start_marketing_date": "19860710",
  "active_numerator_strength": "100"
}
API referenceMCP serverPlans

See everything about doxycycline hyclate.

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.

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