ibuprofen

Product NDC
51293-845
11-digit product format
512930845
Labeler code
51293
Product ID
51293-845_d5a566eb-7e63-ced1-e053-2995a90a6239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ECI PHARMACEUTICALS 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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51293-845-01EA - Each51293-84533a9312d-926a-450d-bb91-66935b015ffb12021-09-07
51293-845-05EA - Each51293-8459abcd358-ed78-420b-b049-4cdbe887abf912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51293-845IBUPROFEN TABLET, FILM COATED [ECI PHARMACEUTICALS LLC]3Legacy NDC20220116_c9b2925e-1ed9-1e00-e053-2995a90a4e70.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51293-845-0151293084501100 TABLET, FILM COATED in 1 BOTTLE (51293-845-01) 2016-11-230000-00-00NoNoCurrent
51293-845-0551293084505500 TABLET, FILM COATED in 1 BOTTLE (51293-845-05) 2016-11-230000-00-00NoNoCurrent