FDA.reportPublic FDA data

Amoxicillin and Clavulanate potassium

Product NDC
69097-098
11-digit product format
690970098
Labeler code
69097
Product ID
69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA065431
Marketing category
ANDA
Marketing start
2024-10-28
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250; 62.5 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
AMOXICILLIN250 mg/5mL
CLAVULANATE POTASSIUM62.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU, Q42OMW3AT8
Rxcui617322

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
69097-098-08Amoxicillin and Clavulanate potassium150 mL in 1 BOTTLESUSPENSION1502
69097-098-43Amoxicillin and Clavulanate potassium75 mL in 1 BOTTLESUSPENSION752
69097-098-44Amoxicillin and Clavulanate potassium100 mL in 1 BOTTLESUSPENSION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-098-08ML - Milliliter69097-09802ec44d8-7ec4-4643-99dc-e3fe0765973f12025-01-14
69097-098-43ML - Milliliter69097-098529a632b-84d3-4e2a-84df-d310c996e94e12025-01-14
69097-098-44ML - Milliliter69097-098d8fe9eb6-be7d-4d48-aa83-009a787b850a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-098AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [CIPLA USA INC.]2Current NDC, 3 package rows20241029_db25500a-90ee-429f-991f-da511cec7882.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617322amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral SuspensionPSNdb25500a-90ee-429f-991f-da511cec78822
617322amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral SuspensionSCDdb25500a-90ee-429f-991f-da511cec78822
617322amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral SuspensionSYdb25500a-90ee-429f-991f-da511cec78822
617322amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral SuspensionSYdb25500a-90ee-429f-991f-da511cec78822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-098-0869097009808150 mL in 1 BOTTLE (69097-098-08) 150 ml2024-10-28NoNoHistorical
69097-098-436909700984375 mL in 1 BOTTLE (69097-098-43) 75 ml2024-10-28NoNoHistorical
69097-098-4469097009844100 mL in 1 BOTTLE (69097-098-44) 100 ml2024-10-28NoNoHistorical