Childrens Ibuprofen

Product NDC
0121-0917
11-digit product format
001210917
Labeler code
0121
Product ID
0121-0917_e1e1b2a4-6261-ad42-e053-2995a90a3407
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA074916
Marketing category
ANDA
Marketing start
1999-04-30
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
0121-0917-000012109170010 TRAY in 1 CASE (0121-0917-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0917-05) 10 tray2020-06-180000-00-00NoNoCurrent