CHILDRENS IBUPROFEN

Product NDC
68001-435
11-digit product format
680010435
Labeler code
68001
Product ID
68001-435_e0dd215d-aaaf-ab02-e053-2a95a90aa4a4
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA209179
Marketing category
ANDA
Marketing start
2020-06-18
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-435-92680010435921 BOTTLE in 1 CARTON (68001-435-92) > 120 mL in 1 BOTTLE1 bottle2020-06-180000-00-00NoNoCurrent
68001-435-94680010435941 BOTTLE in 1 CARTON (68001-435-94) > 240 mL in 1 BOTTLE1 bottle2020-06-180000-00-00NoNoCurrent