ibuprofen

Product NDC
71610-456
11-digit product format
716100456
Labeler code
71610
Product ID
71610-456_b1e690f9-663d-40c1-9803-143678bd96bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202413
Marketing category
ANDA
Marketing start
2016-11-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-456IBUPROFEN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20200902_c9ba5c17-12a8-426d-ad06-2acb344793bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-456-607161004566090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-456-60) 2020-08-270000-00-00NoNoCurrent
71610-456-8071610045680180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-456-80) 2020-08-270000-00-00NoNoCurrent
71610-456-9271610045692270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-456-92) 2020-08-270000-00-00NoNoCurrent