Amoxicillin

Product NDC
70518-4529
11-digit product format
705184529
Labeler code
70518
Product ID
70518-4529_44fb6895-f054-70eb-e063-6394a90a5deb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA050760
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-12-02
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
804826J2HUAMOXICILLIN61336-70-7AMOXICILLIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4529-070518452900100 mL in 1 BOTTLE (70518-4529-0) 100 ml2025-12-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AmoxicillinREMEDYREPACK INC.2025-12-02HUMAN PRESCRIPTION DRUG LABEL1