MedPath

Demeclocycline

Generic Name
Demeclocycline
Drug Type
Small Molecule
Chemical Formula
C21H21ClN2O8
CAS Number
127-33-3
Unique Ingredient Identifier
5R5W9ICI6O

Overview

A tetracycline analog having a 7-chloro and a 6-methyl. Because it is excreted more slowly than tetracycline, it maintains effective blood levels for longer periods of time.

Indication

Used primarily to treat Lyme disease, acne, and bronchitis. Also indicated (but rarely used) to treat urinary tract infections, gum disease, malaria, and other bacterial infections such as gonorrhea and chlamydia. One of its other registered uses is the treatment of hyponatremia (low blood sodium concentration) due to the syndrome of inappropriate antidiuretic hormone (SIADH) where fluid restriction alone has been ineffective.

Associated Conditions

  • Relapsing fever caused by Borrelia recurrentis
  • Tularemia
  • Severe Acne Vulgaris
  • Psittacosis
  • Urinary Tract Infection
  • Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
  • Acute Intestinal amebiasis
  • Conjunctivitis caused by chlamydia
  • Yaws
  • Campylobacter Infection
  • Rickettsia Infections
  • Anthrax
  • Listeria infection
  • Skin Infections caused by Staphylococcus Aureus
  • Chlamydial Infections
  • Clostridium Difficile Infection (CDI)
  • Brucellosis
  • Bartonellosis
  • Chlamydia Trachomatis Infection
  • Gram-Negative Bacterial Infections
  • Plague
  • Actinomycosis
  • Sexually Transmitted Infections (STIs)
  • Cholera (Disorder)
  • Necrotizing ulcerative gingivostomatitis
  • Respiratory Tract Infections (RTI)

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Marlex Pharmaceuticals Inc
10135-626
ORAL
300 mg in 1 1
10/5/2016
Amneal Pharmaceuticals LLC
65162-554
ORAL
150 mg in 1 1
5/18/2018
Epic Pharma, LLC
42806-144
ORAL
300 mg in 1 1
11/8/2023
American Health Packaging
60687-691
ORAL
150 mg in 1 1
2/28/2023
Carilion Materials Management
68151-0155
ORAL
150 mg in 1 1
4/1/2010
American Health Packaging
60687-705
ORAL
300 mg in 1 1
2/28/2023
Amneal Pharmaceuticals LLC
65162-555
ORAL
300 mg in 1 1
5/18/2018
Amneal Pharmaceuticals of New York LLC
53746-555
ORAL
300 mg in 1 1
2/16/2023
PuraCap Laboratories LLC
24658-711
ORAL
300 mg in 1 1
1/3/2019
Amneal Pharmaceuticals of New York LLC
53746-554
ORAL
150 mg in 1 1
2/16/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DECLOMYCIN TAB 150MG
lederle cyanamid canada inc.
00381713
Tablet - Oral
150 MG / TAB
12/31/1977
DECLOMYCIN - TAB 300MG
wyeth-ayerst canada inc.
02169932
Tablet - Oral
300 MG
10/15/1997
DECLOMYCIN TAB 300MG
lederle cyanamid canada inc.
00127744
Tablet - Oral
300 MG / TAB
12/31/1966
DECLOMYCIN
wyeth canada
02169924
Tablet - Oral
150 MG
10/25/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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