AUGMENTIN

Product NDC
72508-004
11-digit product format
725080004
Labeler code
72508
Product ID
72508-004_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
2021-10-01
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
72508-004-07ML - Milliliter72508-00415f23f45-7a11-49f1-8f56-52ab61aec0b312019-04-11
72508-004-10ML - Milliliter72508-00479ac93df-dbb8-4f4a-97bc-8a670f370b0a12019-04-11
72508-004-15ML - Milliliter72508-004ebf5ae28-88c6-419e-8cea-6421f403bfa412019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72508-004-077250800040775 mL in 1 BOTTLE (72508-004-07) 75 ml2019-03-012021-10-01NoNoCurrent
72508-004-1072508000410100 mL in 1 BOTTLE (72508-004-10) 100 ml2019-03-010000-00-00NoNoCurrent
72508-004-1572508000415150 mL in 1 BOTTLE (72508-004-15) 150 ml2019-03-010000-00-00NoNoCurrent