Ibuprofen PM

Product NDC
55910-856
11-digit product format
559100856
Labeler code
55910
Product ID
55910-856_dfa0efe8-ca0f-4aa9-bccd-9cdac7aef39d
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN, DIPHENHYDRAMINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA200888
Marketing category
ANDA
Marketing start
2018-04-30
Marketing end
2025-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength
25 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-856-20559100856201 BOTTLE, PLASTIC in 1 BOX (55910-856-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-302025-01-31NoNoCurrent
55910-856-40559100856401 BOTTLE, PLASTIC in 1 BOX (55910-856-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-302025-01-31NoNoCurrent