Ibuprofen

Product NDC
59556-149
11-digit product format
595560149
Labeler code
59556
Product ID
59556-149_ac8a65ce-e894-49ac-a9a0-9a1b7ce5bd04
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA214071
Marketing category
ANDA
Marketing start
2022-08-09
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59556-149-01595560149011 BOTTLE, DROPPER in 1 CARTON (59556-149-01) > 15 mL in 1 BOTTLE, DROPPER2022-08-090000-00-00NoNoCurrent
59556-149-02595560149021 BOTTLE, DROPPER in 1 CARTON (59556-149-02) > 30 mL in 1 BOTTLE, DROPPER2022-08-090000-00-00NoNoCurrent