Ibuprofen PM

Product NDC
0363-0756
11-digit product format
003630756
Labeler code
0363
Product ID
0363-0756_32780c52-a85c-40d6-8077-9ef80371dddb
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN, DIPHENHYDRAMINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
ANDA200888
Marketing category
ANDA
Marketing start
2018-07-31
Marketing end
2025-08-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0756-20EA - Each0363-0756c3984905-b308-4faf-8306-5e15e9458a9112022-06-06
0363-0756-40EA - Each0363-075602350f36-8470-440c-aeed-30062a97ae9a12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0756IBUPROFEN PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]4Legacy NDC20230120_a4e659cb-75bc-4847-8fd5-d3429f2b00c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0756-20003630756201 BOTTLE, PLASTIC in 1 BOX (0363-0756-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-07-312025-08-31NoNoCurrent
0363-0756-40003630756401 BOTTLE, PLASTIC in 1 BOX (0363-0756-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-07-312025-08-31NoNoCurrent