AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
72508-204
11-digit product format
725080204
Labeler code
72508
Product ID
72508-204_5389440b-425b-4a38-896e-b47005af3f45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Neopharma Inc
Application
NDA050575
Marketing category
NDA
Marketing start
2019-03-01
Marketing end
2021-10-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250 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
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72508-204-07ML - Milliliter72508-2046c06bee4-a4c3-4013-a5a1-880597512b1512019-04-11
72508-204-10ML - Milliliter72508-2046567f4f5-4a00-43ae-aabc-c7f131a7517612019-04-11
72508-204-15ML - Milliliter72508-20402d8a8cb-be03-4fbd-9844-060e468ceea312019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72508-204-077250802040775 mL in 1 BOTTLE (72508-204-07) 75 ml2019-03-010000-00-00NoNoCurrent
72508-204-1072508020410100 mL in 1 BOTTLE (72508-204-10) 100 ml2019-03-010000-00-00NoNoCurrent
72508-204-1572508020415150 mL in 1 BOTTLE (72508-204-15) 150 ml2019-03-010000-00-00NoNoCurrent