FDA.reportPublic FDA data

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
71205-331
11-digit product format
712050331
Labeler code
71205
Product ID
71205-331_32686b6d-d8ac-4f0a-831e-f1bbbf2cf640
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204755
Marketing category
ANDA
Marketing start
2017-03-01
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
71205-331-14AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BOTTLETABLET, FILM COATED144
71205-331-15AMOXICILLIN AND CLAVULANATE POTASSIUM15 in 1 BOTTLETABLET, FILM COATED154
71205-331-20AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, FILM COATED204
71205-331-30AMOXICILLIN AND CLAVULANATE POTASSIUM30 in 1 BOTTLETABLET, FILM COATED304
71205-331-60AMOXICILLIN AND CLAVULANATE POTASSIUM60 in 1 BOTTLETABLET, FILM COATED604
71205-331-90AMOXICILLIN AND CLAVULANATE POTASSIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-331AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20220421_e08c1bee-14c8-4bd1-898c-1874251dadf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNe08c1bee-14c8-4bd1-898c-1874251dadf84
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDe08c1bee-14c8-4bd1-898c-1874251dadf84
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYe08c1bee-14c8-4bd1-898c-1874251dadf84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-331-147120503311414 TABLET, FILM COATED in 1 BOTTLE (71205-331-14) 2020-05-050000-00-00NoNoCurrent
71205-331-157120503311515 TABLET, FILM COATED in 1 BOTTLE (71205-331-15) 2019-10-010000-00-00NoNoCurrent
71205-331-207120503312020 TABLET, FILM COATED in 1 BOTTLE (71205-331-20) 2019-10-010000-00-00NoNoCurrent
71205-331-307120503313030 TABLET, FILM COATED in 1 BOTTLE (71205-331-30) 2019-10-010000-00-00NoNoCurrent
71205-331-607120503316060 TABLET, FILM COATED in 1 BOTTLE (71205-331-60) 2019-10-010000-00-00NoNoCurrent
71205-331-907120503319090 TABLET, FILM COATED in 1 BOTTLE (71205-331-90) 2019-10-010000-00-00NoNoCurrent