FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
0143-9981
11-digit product format
001439981
Labeler code
0143
Product ID
0143-9981_29e9e32b-e9a3-48b5-a1c7-14b3bbe447e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065191
Marketing category
ANDA
Marketing start
2007-12-01
Substance
AMOXICILLIN; CLAVULANIC ACID
Active strength
200; 28.5 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN200 mg/5mL
CLAVULANIC ACID28.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, 23521W1S24
Rxcui617423, 617430

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9981-01Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10014
0143-9981-50Amoxicillin and Clavulanate Potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5014
0143-9981-75Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9981-01ML - Milliliter0143-998144b28470-0c5e-4980-a005-16180b5cc45812012-07-24
0143-9981-50ML - Milliliter0143-9981a41760b2-aaed-4df5-8484-99e544e2074f12012-07-24
0143-9981-75ML - Milliliter0143-99812e735fbc-1d4c-4496-b701-178afd67341012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
CLAVULANIC ACIDACTIVE INGREDIENT23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9981AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 3 package rows20240705_240bcdcb-31d9-40a0-87e1-bd16264a2e20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN240bcdcb-31d9-40a0-87e1-bd16264a2e2014
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN240bcdcb-31d9-40a0-87e1-bd16264a2e2014
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD240bcdcb-31d9-40a0-87e1-bd16264a2e2014
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD240bcdcb-31d9-40a0-87e1-bd16264a2e2014
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY240bcdcb-31d9-40a0-87e1-bd16264a2e2014
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY240bcdcb-31d9-40a0-87e1-bd16264a2e2014
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY240bcdcb-31d9-40a0-87e1-bd16264a2e2014
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY240bcdcb-31d9-40a0-87e1-bd16264a2e2014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9981-0100143998101100 mL in 1 BOTTLE (0143-9981-01) 100 ml2007-12-010000-00-00NoNoCurrent
0143-9981-500014399815050 mL in 1 BOTTLE (0143-9981-50) 50 ml2007-12-010000-00-00NoNoCurrent
0143-9981-750014399817575 mL in 1 BOTTLE (0143-9981-75) 75 ml2007-12-010000-00-00NoNoCurrent