FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
0143-9249
11-digit product format
001439249
Labeler code
0143
Product ID
0143-9249_46aeb040-bd8f-4fcf-bfb7-98a8efc0a368
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 125 mg/1; mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui562508

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
0143-9249-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9249-20EA - Each0143-92498d30faa8-9e4a-4ff7-8163-7c27698bcaec12017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9249AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 1 package rows20250110_52ab3500-d088-4693-acea-9b83c0843f66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a419
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNf229e8b4-7045-4c0d-9214-890c0bda3c2a17
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDf229e8b4-7045-4c0d-9214-890c0bda3c2a17
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYf229e8b4-7045-4c0d-9214-890c0bda3c2a17
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN6a078e7d-f942-4185-a131-50215d8e0a1e15
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD6a078e7d-f942-4185-a131-50215d8e0a1e15
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY6a078e7d-f942-4185-a131-50215d8e0a1e15
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN52ab3500-d088-4693-acea-9b83c0843f6612
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNd213685c-5e67-4130-b00b-7626685dfa1612
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDd213685c-5e67-4130-b00b-7626685dfa1612
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD52ab3500-d088-4693-acea-9b83c0843f6612
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY52ab3500-d088-4693-acea-9b83c0843f6612
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYd213685c-5e67-4130-b00b-7626685dfa1612
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNe5b0770d-1301-498e-a4ed-41874d7bf2256
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDe5b0770d-1301-498e-a4ed-41874d7bf2256
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYe5b0770d-1301-498e-a4ed-41874d7bf2256
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN9015d3dc-1ab4-2582-e053-2995a90a16795
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN9263495c-310a-c20e-e053-2995a90a2e875
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD9015d3dc-1ab4-2582-e053-2995a90a16795
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD9263495c-310a-c20e-e053-2995a90a2e875
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY9015d3dc-1ab4-2582-e053-2995a90a16795
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY9263495c-310a-c20e-e053-2995a90a2e875
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN8dba4e86-5f79-0bea-e053-2a95a90a9e2d4
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD8dba4e86-5f79-0bea-e053-2a95a90a9e2d4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY7989371d-feed-6c25-e053-2991aa0a967d4
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY8dba4e86-5f79-0bea-e053-2a95a90a9e2d4
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNb0d7eb3e-706a-482b-b106-9c137be55bb62
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDb0d7eb3e-706a-482b-b106-9c137be55bb62
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYb0d7eb3e-706a-482b-b106-9c137be55bb62
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN67b8567a-bab7-4859-88d6-c2ea695b9f0a1
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN9af14455-3286-8f6e-e053-2a95a90a60341
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD9af14455-3286-8f6e-e053-2a95a90a60341
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD67b8567a-bab7-4859-88d6-c2ea695b9f0a1
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY67b8567a-bab7-4859-88d6-c2ea695b9f0a1
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY9af14455-3286-8f6e-e053-2a95a90a60341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9249-200014392492020 TABLET in 1 BOTTLE (0143-9249-20) 20 tablet2016-08-230000-00-00NoNoCurrent