Amoxicillin

Product NDC
53002-2091
11-digit product format
530022091
Labeler code
53002
Product ID
53002-2091_40de640c-3898-4fc4-89b2-1988be9151de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA061931
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
804826J2HUAMOXICILLIN61336-70-7AMOXICILLIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2091-15300220910180 mL in 1 BOTTLE (53002-2091-1) 80 ml2019-01-010000-00-00NoNoCurrent
53002-2091-253002209102100 mL in 1 BOTTLE (53002-2091-2) 100 ml2019-01-010000-00-00NoNoCurrent
53002-2091-353002209103150 mL in 1 BOTTLE (53002-2091-3) 150 ml2019-01-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AmoxicillinRPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL3