CHILDRENS IBUPROFEN

Product NDC
58602-200
11-digit product format
586020200
Labeler code
58602
Product ID
58602-200_a5e55642-8e21-4274-98b2-a49637fadbf8
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA209179
Marketing category
ANDA
Marketing start
2018-04-17
Marketing end
2023-09-30
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-200-20586020200201 BOTTLE in 1 CARTON (58602-200-20) > 240 mL in 1 BOTTLE1 bottle2018-04-170000-00-00NoNoCurrent
58602-200-24586020200241 BOTTLE in 1 CARTON (58602-200-24) > 120 mL in 1 BOTTLE1 bottle2018-04-172023-09-30NoNoCurrent