Ibuprofen

Product NDC
55319-046
11-digit product format
553190046
Labeler code
55319
Product ID
55319-046_6403a89b-ae4d-42e5-9a5c-d51613f0f42a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA207753
Marketing category
ANDA
Marketing start
2020-06-30
Marketing end
2025-06-30
Substance
IBUPROFEN
Active strength
200 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
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-046IBUPROFEN CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]2Legacy NDC20221101_ff13ff8f-ef17-4d08-bd44-058a080c8c61.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-046-1655319004616160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (55319-046-16) 2020-06-300000-00-00NoNoCurrent
55319-046-20553190046201 BOTTLE, PLASTIC in 1 BOX (55319-046-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-06-300000-00-00NoNoCurrent