Ibuprofen

Product NDC
42291-440
11-digit product format
422910440
Labeler code
42291
Product ID
42291-440_d57cc4c3-b774-5ff8-e053-2995a90afadd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA078329
Marketing category
ANDA
Marketing start
2020-09-03
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42291-440-952024-10-08C16284748780-10191ceaa-61ba-198a-e063-dbdaa90aec3eae6f8fb6-2b48-9464-e053-2995a90a04c6
42291-440-952023-07-28C16284748780-10191ceaa-61ba-198a-e063-dbdaa90aec3eae6f8fb6-2b48-9464-e053-2995a90a04c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-440-9542291044095500 TABLET, FILM COATED in 1 BOTTLE (42291-440-95) 2020-09-030000-00-00NoNoCurrent