FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
16714-294
11-digit product format
167140294
Labeler code
16714
Product ID
16714-294_04e2b9cd-a5cb-4762-86f9-1afbd53b4bc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA201091
Marketing category
ANDA
Marketing start
2011-12-20
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600; 42.9 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
AMOXICILLIN600 mg/5mL
CLAVULANATE POTASSIUM42.9 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617993

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
16714-294-01Amoxicillin and Clavulanate Potassium75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7516
16714-294-02Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION12516
16714-294-03Amoxicillin and Clavulanate Potassium200 mL in 1 BOTTLEPOWDER, FOR SUSPENSION20016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-294-01ML - Milliliter16714-294ad283d80-2f6b-4137-a4f6-ccef6573fc2c12012-07-24
16714-294-02ML - Milliliter16714-29420d80f3b-4c86-4563-a54b-d79e5ae6168012012-07-24
16714-294-03ML - Milliliter16714-29401ac83bc-a0a1-456a-afcb-662ec7f56a4c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-294AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC]16Current NDC, Legacy NDC, 3 package rows20250507_df4136c0-9efd-42c3-a487-e728e8b91275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNccb8bfb1-1303-4c2d-9106-78684e6b859f17
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDccb8bfb1-1303-4c2d-9106-78684e6b859f17
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYccb8bfb1-1303-4c2d-9106-78684e6b859f17
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYccb8bfb1-1303-4c2d-9106-78684e6b859f17
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNdf4136c0-9efd-42c3-a487-e728e8b9127516
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDdf4136c0-9efd-42c3-a487-e728e8b9127516
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYdf4136c0-9efd-42c3-a487-e728e8b9127516
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYdf4136c0-9efd-42c3-a487-e728e8b9127516
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNbcd19a89-e9dc-b85f-e053-2a95a90a6f3e3
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDbcd19a89-e9dc-b85f-e053-2a95a90a6f3e3
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYbcd19a89-e9dc-b85f-e053-2a95a90a6f3e3
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYbcd19a89-e9dc-b85f-e053-2a95a90a6f3e3
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNebf49514-0bce-ac56-e053-2a95a90ae5402
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDebf49514-0bce-ac56-e053-2a95a90ae5402
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYebf49514-0bce-ac56-e053-2a95a90ae5402
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYebf49514-0bce-ac56-e053-2a95a90ae5402
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSNe05caabb-b95c-4e54-890e-bbc371a20fc31
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN5250085e-5509-c577-e063-6294a90a9b871
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCDe05caabb-b95c-4e54-890e-bbc371a20fc31
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD5250085e-5509-c577-e063-6294a90a9b871
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSYe05caabb-b95c-4e54-890e-bbc371a20fc31
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY5250085e-5509-c577-e063-6294a90a9b871
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY5250085e-5509-c577-e063-6294a90a9b871
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSYe05caabb-b95c-4e54-890e-bbc371a20fc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-294-011671402940175 mL in 1 BOTTLE (16714-294-01) 75 ml2011-12-200000-00-00NoNoCurrent
16714-294-0216714029402125 mL in 1 BOTTLE (16714-294-02) 125 ml2011-12-200000-00-00NoNoCurrent
16714-294-0316714029403200 mL in 1 BOTTLE (16714-294-03) 200 ml2011-12-200000-00-00NoNoCurrent