Ibuprofen and Pseudoephedrine hydrochloride

Product NDC
63629-5284
11-digit product format
636295284
Labeler code
63629
Product ID
63629-5284_7249b0f9-b24c-4f7f-81f2-22473a4d5b0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen and pseudoephedrine hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074567
Marketing category
ANDA
Marketing start
2001-10-13
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5284-16362952840130 TABLET, SUGAR COATED in 1 BOTTLE (63629-5284-1) 2022-02-080000-00-00NoNoCurrent
63629-5284-26362952840220 TABLET, SUGAR COATED in 1 BOTTLE (63629-5284-2) 2014-03-310000-00-00NoNoCurrent