AUGMENTIN

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Croatia, Cyprus, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Tunisia, Turkey, UK, United States.

Active ingredients

The drug AUGMENTIN contains a combination of these active pharmaceutical ingredients (APIs):

1	Amoxicillin trihydrate UNII 544Y3D6MYH - AMOXICILLIN SODIUM
	Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.
	Read more about Amoxicillin
2	Clavulanic acid UNII Q42OMW3AT8 - CLAVULANATE POTASSIUM
	Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin.
	Read more about Clavulanic acid

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-1928	Tablet	Augmentin 625 mg TAB 500 mg; 125 mg 2 x 7's (in Alu-Alu blisters)	A white to off-white oval-shaped film-coated tablet, debossed with ‘AC’ and a score line on one side and plain on the other side	26/04/2023
04-2466	Tablet	Augmentin Tablets 375 mg TAB 250 mg; 125 mg 2 x 10's (in blisters)	A white to off-white oval-shaped film-coated tablet, debossed with ‘Augmentin’ on one side	26/04/2023
04-2496	Powder for suspension	Augmentin 457 mg/5 mL Powder for Oral Suspension PWD_F_SOL 400 mg/5 mL; 57 mg/5 mL 70 mL (in clear glass bottle)	Powder for oral suspension. Off-white powder	26/02/2020
04-2516	Powder for suspension	Augmentin PWD_F_SOL 200 mg/5 mL; 28.5 mg/5 mL 70 mL (in clear glass bottle)	Powder for oral suspension. White to off-white powder	26/02/2020
04-8655	Tablet	Augmentin 1 G TAB 875 mg; 125 mg 2 x 7's (in Alu-Alu blisters)	A white to off-white capsule-shaped film-coated tablet, debossed with ‘AC’ on both sides and a score line on one side	26/04/2023
B4-0052	Powder for suspension	Augmentin ES Powder for Oral Suspension PWD_F_SOL 600 mg/5 mL; 42.9 mg/5 mL	Powder for Oral Suspension. Off-white powder which, when reconstituted, yields an off-white to tan coloured, strawberry flavoured suspension	21/12/2020

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
AUGMENTIN Powder for suspension / Film coated-tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
J01CR02	Amoxicillin and enzyme inhibitor	J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01C Beta-lactam antibacterials, penicillins → J01CR Combinations of penicillins, incl. beta-lactamase inhibitors
Discover more medicines within J01CR02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	11933C, 11941L, 1891M, 5006L, 5008N, 5011R, 8254K, 8319W
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	21.881-1-04-05, 28907-06-09, 29028-09-09, 29086-11-09, 29261-06-10, 29263-06-10, 5406-MEE-0820, 5472-MEE-0920, 5473-MEE-0920, 946-MEE-0415
EE	Ravimiamet	1028629, 1028630, 1028641, 1028685, 1066733, 1091012, 1614204, 1623484, 1623495, 1623507, 1623518, 1623529, 1623530, 1623541, 1623552, 1623563, 1623574, 1623585, 1623596, 1623608, 1623619, 1623620, 1623642, 1623653, 1677135, 1677146, 1677157, 1677168, 1677179, 1677180, 1677191, 1677203, 1677214, 1677225, 1677236, 1718322, 1718333, 1718344, 1723092, 1723104, 1723115, 1723126, 1723137, 1723148, 1723160, 1723171, 1723182, 1738313, 1740327, 1740338, 1770937, 1770948, 1770959, 1822698, 1822700, 1822711, 1840700, 1840722, 1864649, 1864650, 1864661, 1864672, 1864683, 1864694, 1864706, 1864717, 1864728, 1864739, 1864740, 1865088
FR	Base de données publique des médicaments	63084015, 63565244, 64582182, 66053338, 66853013, 69325964, 69978246
GB	Medicines & Healthcare Products Regulatory Agency	138327, 138330, 141991, 141993, 14682, 14684, 14738, 14743, 14780, 14826, 161395, 161397, 180512, 185457, 196924, 27822, 27824, 381178, 381183
HK	Department of Health Drug Office	24658, 27421, 27422, 42252, 42735, 44027, 47298
HR	Agencija za lijekove i medicinske proizvode	HR-H-170450439, HR-H-377920132
IE	Health Products Regulatory Authority	13428, 13521, 13534, 14267, 91103, 91107, 91115, 91125, 91134, 91154
IL	מִשְׂרַד הַבְּרִיאוּת	2637, 3057, 3105, 3666, 3818, 3819, 6799
IT	Agenzia del Farmaco	026089019, 026089108, 026089110, 026089122, 026089134, 026089464, 026089502, 026089514, 037954070, 037954082, 037954094, 037954106, 037954118, 038291047, 038291050, 038291086, 039785050, 039785062, 039785074, 039785086, 039785098, 039785100, 040488049, 040488052, 040488076, 041267030, 041267042, 042212023, 042856068, 042902039, 042918058, 042918060, 043388026
JP	医薬品医療機器総合機構	6139100F1048, 6139100F2044
LT	Valstybinė vaistų kontrolės tarnyba	1002258, 1002259, 1002260, 1003780, 1004342, 1004909, 1021696, 1021697, 1021698, 1025237, 1025238, 1025239, 1025240, 1071551, 1071552, 1071553, 1071554, 1071556, 1071557, 1071558, 1071559, 1071560, 1071561, 1071562, 1071563, 1071564, 1071565, 1071566, 1071567, 1071568, 1071569, 1071570, 1071571, 1071572, 1071573, 1071574, 1071575, 1078641, 1080501, 1080502, 1081963, 1081964, 1084662
MT	Medicines Authority	AA1051/00101, AA729/31601, MA192/01501, MA192/01502, MA192/01503, MA192/01504, MA192/01505, PI521/02301D, PI521/02305A, PI908/01301A, PI908/01301B, PI908/01302A, PI908/01304B, PI908/01305A, PI908/01305B
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	068M82, 079M84, 141M98, 231M2003, 587M97
NG	Registered Drug Product Database	04-1928, 04-2466, 04-2496, 04-2516, 04-8655, B4-0052
NL	Z-Index G-Standaard	13680285
NL	Z-Index G-Standaard, PRK	43079, 88684
NZ	Medicines and Medical Devices Safety Authority	3328, 3330, 3331, 3333, 3334
PL	Rejestru Produktów Leczniczych	100008292, 100008300, 100074969, 100086955, 100110659, 100162567, 100174889, 100254720, 100255441, 100264204, 100292258, 100292940, 100312251, 100313546, 100325510, 100336903, 100338262, 100358260, 100371450, 100371785, 100405260, 100419492, 100431910, 100451151, 100454412
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65088001, W65088002, W65088003, W65088004, W65088005, W65088006, W65088007, W65088008, W65088009, W65088010, W65088011, W65088012, W65088013, W65089001, W65089002, W65089003, W65089004, W65089005, W65089006, W65089007, W65089008, W65089009, W65089010, W65089011, W65089012, W65099001, W65099002, W65099003, W65099004, W67768001, W67768002, W67768003, W67768004, W67768005, W67768006, W67768007, W67768008
SG	Health Sciences Authority	01685P, 01686P, 08956P, 09827P, 09831P, 09832P, 13201P, 14689P
TN	Direction de la Pharmacie et du Médicament	90435610, 9043563, 9043564, 9043565, 9043566, 9043567, 9043568, 9043569
TR	İlaç ve Tıbbi Cihaz Kurumu	8699522095605, 8699522095612, 8699522095650, 8699522095667, 8699522095704, 8699522095711, 8699522285754, 8699522285792, 8699522285808, 8699522285822, 8699522288519
US	FDA, National Drug Code	72508-004, 72508-006, 72508-012, 72508-018, 72508-021
ZA	Health Products Regulatory Authority	32/20.1.2/0239, 36/20.1.2/0288, 36/20.1.2/0366, 36/20.1.2/0367, A39/20.1.2/0130, U/20.1.2/49, U/20.1.2/50