AUGMENTIN

Product NDC
61919-391
11-digit product format
619190391
Labeler code
61919
Product ID
61919-391_36fb1fec-f0f6-6d2f-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOX/CLAV.POT.ORAL SUSP
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Direct_Rx
Application
ANDA065191
Marketing category
ANDA
Marketing start
2015-11-09
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANIC ACID
Active strength
400 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
2020-12-31
Current FDA listing
Historical FDA.report record

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
61919-391-32AUGMENTIN5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-391-32ML - Milliliter61919-391b14d7ba7-5bfb-47b2-8e50-9f8b54559aea12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-391AUGMENTIN (AMOX/CLAV.POT.ORAL SUSP) POWDER, FOR SUSPENSION [DIRECT_RX]1Legacy NDC, 1 package rows20190802_36fb1fec-f0f5-6d2f-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617430amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral SuspensionPSN36fb1fec-f0f5-6d2f-e054-00144ff88e881
617432amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension [Augmentin]SBD36fb1fec-f0f5-6d2f-e054-00144ff88e881
617430amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral SuspensionSCD36fb1fec-f0f5-6d2f-e054-00144ff88e881
617430amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral SuspensionSY36fb1fec-f0f5-6d2f-e054-00144ff88e881
617430amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral SuspensionSY36fb1fec-f0f5-6d2f-e054-00144ff88e881
617432Augmentin (amoxicillin 400 MG / clavulanate 57 MG) per 5 ML Oral SuspensionSY36fb1fec-f0f5-6d2f-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61919-391-32619190391325 mL in 1 BOTTLE5 mlHistorical