AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC
72508-203
11-digit product format
725080203
Labeler code
72508
Product ID
72508-203_256c881f-2ff6-4af4-876c-fc860860e3a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Neopharma Inc
Application
NDA050755
Marketing category
NDA
Marketing start
2020-02-18
Marketing end
2022-06-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600 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
72508-203-51ML - Milliliter72508-20315c9522d-981b-4624-a4fa-92f381fec90c12020-09-14
72508-203-54ML - Milliliter72508-20386ae9561-39b1-49fa-8542-6a9fdfb9c96312020-09-14
72508-203-69ML - Milliliter72508-2038ec5ba64-0798-4e6d-b3a2-032fc19937e012020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72508-203-517250802035175 mL in 1 BOTTLE (72508-203-51) 75 ml2020-02-182022-06-01NoNoCurrent
72508-203-5472508020354200 mL in 1 BOTTLE (72508-203-54) 200 ml2020-02-182022-06-01NoNoCurrent
72508-203-6972508020369125 mL in 1 BOTTLE (72508-203-69) 125 ml2020-02-182022-06-01NoNoCurrent