FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
70882-111
11-digit product format
708820111
Labeler code
70882
Product ID
70882-111_f0063b1e-af9e-474d-96b9-0b3aa1a37ea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cambridge Therapeutics Technologies, LLC
Application
ANDA065189
Marketing category
ANDA
Marketing start
2005-08-23
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
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
AMOXICILLIN250 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui562251

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
70882-111-20Amoxicillin and Clavulanate Potassium20 in 1 BLISTER PACKTABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70882-111-20EA - Each70882-11174982130-6b50-488f-bec0-d093ded4b40712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70882-111AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC]1Current NDC, Legacy NDC, 1 package rows20161216_a4c9694c-f539-470e-bfe3-8723fa1c343d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562251amoxicillin 250 MG / clavulanate potassium 125 MG Oral TabletPSNa4c9694c-f539-470e-bfe3-8723fa1c343d1
562251amoxicillin 250 MG / clavulanate 125 MG Oral TabletSCDa4c9694c-f539-470e-bfe3-8723fa1c343d1
562251amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYa4c9694c-f539-470e-bfe3-8723fa1c343d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70882-111-207088201112020 TABLET, FILM COATED in 1 BLISTER PACK (70882-111-20) 2005-08-230000-00-00NoNoCurrent