Ibuprofen

Product NDC
58657-680
11-digit product format
586570680
Labeler code
58657
Product ID
58657-680_9d53122c-b5f8-1472-e053-2a95a90a971c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA202413
Marketing category
ANDA
Marketing start
2017-04-15
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-680-01EA - Each58657-68017122841-8e6c-44b3-b449-23c4c706a32112017-05-04
58657-680-50EA - Each58657-680357e6dc7-708d-4c8f-b1ca-1e110035e8aa12017-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-680-0158657068001100 TABLET in 1 BOTTLE (58657-680-01) 100 tablet2017-04-150000-00-00NoNoCurrent
58657-680-5058657068050500 TABLET in 1 BOTTLE (58657-680-50) 500 tablet2017-04-150000-00-00NoNoCurrent