IBUPROFEN

Product NDC
0121-1548
11-digit product format
001211548
Labeler code
0121
Product ID
0121-1548_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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-1548-402022-12-02C16284748780-1d6a99b39-e9ef-a426-e053-dadaa90af4c295f98c31-72db-4324-9059-e601d24d0302
0121-1548-402022-01-28C16284748780-1d6a99b39-e9ef-a426-e053-dadaa90af4c295f98c31-72db-4324-9059-e601d24d0302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1548-40001211548404 TRAY in 1 CASE (0121-1548-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-1548-10) 4 tray2017-12-110000-00-00NoNoCurrent