FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
16714-292
11-digit product format
167140292
Labeler code
16714
Product ID
16714-292_581a5622-f3ca-4a4f-9241-9810694c791a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA201090
Marketing category
ANDA
Marketing start
2011-12-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200; 28.5 mg/5mL; mg/5mL
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
AMOXICILLIN200 mg/5mL
CLAVULANATE POTASSIUM28.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617423, 617430

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
16714-292-01Amoxicillin and Clavulanate Potassium50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5013
16714-292-02Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7513
16714-292-03Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-292-01ML - Milliliter16714-292b2c25b93-e944-4fcf-aefa-61c49b7655ab12012-07-24
16714-292-02ML - Milliliter16714-2920a2b4276-deba-40e6-a11f-3109a16eda2f12012-07-24
16714-292-03ML - Milliliter16714-292cf735c62-a8a1-424b-bd6c-b7e23347ea1712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-292AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]13Current NDC, Legacy NDC, 3 package rows20240723_f0a6d21d-203f-4fde-b010-a2730b86b491.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSNf0a6d21d-203f-4fde-b010-a2730b86b49113
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSNf0a6d21d-203f-4fde-b010-a2730b86b49113
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCDf0a6d21d-203f-4fde-b010-a2730b86b49113
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCDf0a6d21d-203f-4fde-b010-a2730b86b49113
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSYf0a6d21d-203f-4fde-b010-a2730b86b49113
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSYf0a6d21d-203f-4fde-b010-a2730b86b49113
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSYf0a6d21d-203f-4fde-b010-a2730b86b49113
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSYf0a6d21d-203f-4fde-b010-a2730b86b49113
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN61f9224b-a91b-4154-a7f3-22c14601230f3
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD61f9224b-a91b-4154-a7f3-22c14601230f3
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY61f9224b-a91b-4154-a7f3-22c14601230f3
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY61f9224b-a91b-4154-a7f3-22c14601230f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-292-011671402920150 mL in 1 BOTTLE (16714-292-01) 50 ml2011-12-200000-00-00NoNoCurrent
16714-292-021671402920275 mL in 1 BOTTLE (16714-292-02) 75 ml2011-12-200000-00-00NoNoCurrent
16714-292-0316714029203100 mL in 1 BOTTLE (16714-292-03) 100 ml2011-12-200000-00-00NoNoCurrent