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Drug ReportsAmoxicillin
Amoxicillin
Amoxicillin, Amoxicillin /, Amoxicillin / /, Amoxil, Augmentin, Larotid, Omeclamox-pak, Talicia, Voquezna (amoxicillin) is a small molecule pharmaceutical. Amoxicillin was first approved as Amoxil on 1982-01-01. It is used to treat actinomycosis, bacterial infections, bacterial skin diseases, chlamydia infections, and duodenal ulcer amongst others in the USA.
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
wounds and injuriesD014947
Trade Name
FDA
EMA
Amoxicillin, Amoxil (discontinued: Amoxicillin, Amoxil, Dispermox, Larotid, Moxatag, Polymox, Trimox, Utimox, Wymox)
Combinations
Amoxicillin clavulanate potassium, Augmentin, Lansoprazole, amoxicillin clarithromycin, Talicia, Voquezna dual, Voquezna triple (discontinued: Amoxicillin clavulanate potassium, Augmentin, Lansoprazole, amoxicillin clarithromycin, Omeclamox-pak, Prevpac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
Tradename
Company
Number
Date
Products
AMOXILUSAntibioticsN-050760 RX1999-04-15
1 products, RLD
Show 8 discontinued
Amoxicillin
+
Clarithromycin
+
Lansoprazole
Tradename
Company
Number
Date
Products
PREVPAC (COPACKAGED)TakedaN-050757 DISCN1997-12-02
1 products, RLD
Hide discontinued
Amoxicillin
+
Omeprazole magnesium
+
Rifabutin
Tradename
Company
Number
Date
Products
TALICIARedHill BiopharmaN-213004 RX2019-11-01
1 products, RLD, RS
Amoxicillin
+
Clarithromycin
+
Omeprazole
Tradename
Company
Number
Date
Products
OMECLAMOX-PAKCumberland PharmaceuticalsN-050824 DISCN2011-02-08
1 products, RLD
Hide discontinued
Amoxicillin
+
Vonoprazan fumarate
Tradename
Company
Number
Date
Products
VOQUEZNA DUAL PAKPhathom PharmaceuticalsN-215153 RX2022-05-03
1 products, RLD, RS
Amoxicillin
+
Clarithromycin
+
Vonoprazan fumarate
Tradename
Company
Number
Date
Products
VOQUEZNA TRIPLE PAKPhathom PharmaceuticalsN-215152 RX2022-05-03
1 products, RLD, RS
Amoxicillin
+
Clavulanate potassium
Tradename
Company
Number
Date
Products
AUGMENTIN '125'USAntibioticsN-050575 RX1984-08-06
1 products, RLD
AUGMENTIN '250'USAntibioticsN-050575 RX1984-08-06
1 products, RLD, RS
AUGMENTIN '875'USAntibioticsN-050720 RX1996-02-13
1 products, RLD
AUGMENTIN ES-600USAntibioticsN-050755 RX2001-06-22
1 products, RLD
Show 9 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amoclan2009-01-07
amoxicillinANDA2025-01-03
amoxicillin 500 mgANDA2022-12-20
amoxicillin amoxicillin and clavulanate potassiumANDA2024-01-09
amoxicillin and clavulanate potassiumANDA2024-11-26
amoxicillin and clavulanate potassium extended releaseNew Drug Application2011-04-07
amoxicillin clav/pot amoxicillin/clav potANDA2023-04-20
amoxicillin clavulanate potassium2006-11-03
amoxicillin/clav pot oral suspANDA2022-08-08
amoxilANDA2023-01-12
Show 10 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
urinary tract infectionsEFO_0003103D014552N39.0
sinusitisEFO_0007486D012852J32
otitis mediaEFO_0004992D010033H66.9
bacterial infections—D001424A49
bacterial skin diseases—D017192—
soft tissue infections—D018461—
chlamydia infectionsEFO_0007205D002690A74.9
helicobacter infectionsEFO_1000961D016481—
duodenal ulcerEFO_0004607D004381K26
streptococcal infectionsEFO_1001476D013290—
Show 20 more
Agency Specific
FDA
EMA
Expiration
Code
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM
2032-05-03GAIN
2027-05-03NCE
AMOXICILLIN / VONOPRAZAN FUMARATE, VOQUEZNA DUAL PAK, PHATHOM
2032-05-03GAIN
2027-05-03NCE
AMOXICILLIN / OMEPRAZOLE MAGNESIUM / RIFABUTIN, TALICIA, REDHILL
2027-11-01GAIN
2022-11-01NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill
118780112042-05-27U-3816
90502632034-02-12DPU-2660
94984452034-02-12DPU-2660
96038062034-02-12DPU-2660
102386062034-02-12DP
111351722034-02-12DPU-2660
Amoxicillin / Clarithromycin / Vonoprazan Fumarate, Voquezna Triple Pak, Phathom
91864112030-08-11DP
79774882028-08-11DP
Amoxicillin, Moxatag, Pragma
82990522027-05-07U-1304
83573942026-12-08DP
87789242026-12-08DS, DPU-897
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD01: Omeprazole, amoxicillin and metronidazole
— A02BD03: Lansoprazole, amoxicillin and metronidazole
— A02BD04: Pantoprazole, amoxicillin and clarithromycin
— A02BD05: Omeprazole, amoxicillin and clarithromycin
— A02BD06: Esomeprazole, amoxicillin and clarithromycin
— A02BD07: Lansoprazole, amoxicillin and clarithromycin
— A02BD10: Lansoprazole, amoxicillin and levofloxacin
— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole
— A02BD12: Rabeprazole, amoxicillin and clarithromycin
— A02BD13: Rabeprazole, amoxicillin and metronidazole
— A02BD14: Vonoprazan, amoxicillin and clarithromycin
— A02BD15: Vonoprazan, amoxicillin and metronidazole
— A02BD16: Omeprazole, amoxicillin and rifabutin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01C: Beta-lactam antibacterials, penicillins
— J01CA: Penicillins with extended spectrum
— J01CA04: Amoxicillin
— J01CR: Combinations of penicillins, incl. beta-lactamase inhibitors
— J01CR02: Amoxicillin and beta-lactamase inhibitor
HCPCS
Code
Description
G9313
Amoxicillin, with or without clavulanate, not prescribed as first line antibiotic at the time of diagnosis for documented reason
G9314
Amoxicillin, with or without clavulanate, not prescribed as first line antibiotic at the time of diagnosis, reason not given
G9315
Amoxicillin, with or without clavulanate, prescribed as a first line antibiotic at the time of diagnosis
Clinical
Clinical Trials
947 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GastritisD005756EFO_0000217K29.72—1—14
Stomach ulcerD013276—K25——1—12
Duodenal ulcerD004381EFO_0004607K26——1—12
UlcerD014456MPATH_579———2——2
InfectionsD007239EFO_0000544———1——1
Helicobacter infectionsD016481EFO_1000961———1——1
PouchitisD019449EFO_0003921K91.850——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphoma marginal zoneD018442—C88.4————11
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3————11
Thrombocytopenic purpuraD011696——————11
PurpuraD011693HP_0000979D69.2————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmoxicillin
INNamoxicillin
Description
Amoxicillin is a penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group. It has a role as an antibacterial drug. It is a penicillin and a penicillin allergen. It is a conjugate acid of an amoxicillin(1-).
Classification
Small molecule
Drug classpenicillins
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1(C)S[C@@H]2[C@H](NC(=O)[C@H](N)c3ccc(O)cc3)C(=O)N2[C@H]1C(=O)O
Identifiers
PDB—
CAS-ID26787-78-0
RxCUI—
ChEMBL IDCHEMBL1082
ChEBI ID2676
PubChem CID33613
DrugBankDB01060
UNII ID9EM05410Q9 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Amoxicillin
Total medical expenditures per year (USD, in millions)
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Amoxicillin
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Lansoprazole
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Clarithromycin
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Amoxicillin
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Omeprazole
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Clarithromycin
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Amoxicillin
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Clavulanate
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 73,576 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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63,478 adverse events reported
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