IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDE

Product NDC
70000-0602
11-digit product format
700000602
Labeler code
70000
Product ID
70000-0602_b5d6426e-cfcc-40c9-b289-c2365eaf0fbb
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC DBA LEADER
Application
ANDA074567
Marketing category
ANDA
Marketing start
2022-05-23
Marketing end
0000-00-00
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0602-1EA - Each70000-06029b06d9fb-2224-418d-9db2-58c4e11cab2512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0602IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 110, LLC DBA LEADER]2Legacy NDC20220601_2cccc119-8eea-4280-9ad9-ec29caf26940.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0602-17000006020140 TABLET in 1 BLISTER PACK (70000-0602-1) 40 tablet2022-05-230000-00-00NoNoCurrent