IBUPROFEN

Product NDC
0121-4774
11-digit product format
001214774
Labeler code
0121
Product ID
0121-4774_61fabc0c-4e17-793e-e053-2a91aa0a4f4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA076925
Marketing category
ANDA
Marketing start
2004-09-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-4774-10001214774104 TRAY in 1 CASE (0121-4774-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE4 tray2017-12-110000-00-00NoNoCurrent
0121-4774-40001214774404 TRAY in 1 CASE (0121-4774-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4774-05) 4 tray2017-12-110000-00-00NoNoCurrent