FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
60687-781
11-digit product format
606870781
Labeler code
60687
Product ID
60687-781_4c5fbf4c-ad51-58fd-e063-6294a90a8133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA091569
Marketing category
ANDA
Marketing start
2024-07-26
Marketing end
2026-11-30
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250; 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN250 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ42OMW3AT8, 804826J2HU
Rxcui562251, 562508, 617296

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
60687-781-11Amoxicillin and Clavulanate Potassium1 in 1 BLISTER PACKTABLET, FILM COATED14
60687-781-94Amoxicillin and Clavulanate Potassium20 in 1 CARTONTABLET, FILM COATED204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-781-11EA - Each60687-7812d5f8d03-2b73-4900-9459-a2ec33e00c3c12024-04-05
60687-781-94EA - Each60687-7815fef0e0d-51eb-452b-bd63-f1f15726d27412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-781AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3Current NDC, 2 package rows20241215_4966a3f2-eed2-4081-ba88-310a3d1964b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSN4966a3f2-eed2-4081-ba88-310a3d1964b44
617296amoxicillin 500 MG / clavulanate potassium 125 MG Oral TabletPSN4966a3f2-eed2-4081-ba88-310a3d1964b44
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSN4966a3f2-eed2-4081-ba88-310a3d1964b44
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCD4966a3f2-eed2-4081-ba88-310a3d1964b44
617296amoxicillin 500 MG / clavulanate 125 MG Oral TabletSCD4966a3f2-eed2-4081-ba88-310a3d1964b44
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCD4966a3f2-eed2-4081-ba88-310a3d1964b44
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY4966a3f2-eed2-4081-ba88-310a3d1964b44
617296amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY4966a3f2-eed2-4081-ba88-310a3d1964b44
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSY4966a3f2-eed2-4081-ba88-310a3d1964b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-781-11606870781111 in 1 BLISTER PACKHistorical
60687-781-946068707819420 BLISTER PACK in 1 CARTON (60687-781-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-781-11) 20 blister pack2024-07-262026-11-30NoNoHistorical