FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50090-4413
11-digit product format
500904413
Labeler code
50090
Product ID
50090-4413_048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091568
Marketing category
ANDA
Marketing start
2012-01-20
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4413-02024-02-15C16284748780-1f386c649-b502-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
50090-4413-02023-01-30C16284748780-1f386c649-b502-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4413-0Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED209
50090-4413-0Amoxicillin and Clavulanate Potassium48 in 1 CASETABLET, FILM COATED489
50090-4413-1Amoxicillin and Clavulanate Potassium24 in 1 CASETABLET, FILM COATED249
50090-4413-1Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4413-0EA - Each50090-44131fa9430c-b09b-47d1-96a7-55eae001c87212024-03-12
50090-4413-1EA - Each50090-44139aa60b0b-009e-4aec-88e7-b96e3722dfd812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4413AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 4 package rows20240517_aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNaaa35f65-cb9c-4b37-a126-c5ff2c2ef79d9
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDaaa35f65-cb9c-4b37-a126-c5ff2c2ef79d9
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYaaa35f65-cb9c-4b37-a126-c5ff2c2ef79d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4413-05009044130048 BOTTLE in 1 CASE (50090-4413-0) / 20 TABLET, FILM COATED in 1 BOTTLE48 bottle2019-07-160000-00-00NoNoCurrent
50090-4413-15009044130124 BOTTLE in 1 CASE (50090-4413-1) / 20 TABLET, FILM COATED in 1 BOTTLE24 bottle2024-02-14NoNoCurrent