AUGMENTIN

Product NDC
72508-012
11-digit product format
725080012
Labeler code
72508
Product ID
72508-012_ec33a4fa-973d-4df0-9ff6-05afbd3eefe0
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
2021-09-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
125 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
72508-012-01ML - Milliliter72508-012c1cbb78d-dcef-4c3d-b184-2a248fb98d2a12019-04-11
72508-012-03ML - Milliliter72508-012922aa784-18fd-4133-a208-9c1cc0361f0812019-04-11
72508-012-05ML - Milliliter72508-0121ae4bb0c-2063-4fb8-8979-26db27c4ea1512019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72508-012-017250800120175 mL in 1 BOTTLE (72508-012-01) 75 ml2019-03-012021-09-01NoNoCurrent
72508-012-0372508001203100 mL in 1 BOTTLE (72508-012-03) 100 ml2019-03-012021-09-01NoNoCurrent
72508-012-0572508001205150 mL in 1 BOTTLE (72508-012-05) 150 ml2019-03-012021-09-01NoNoCurrent