Loratadine and Pseudoephedrine

Product NDC
63629-7766
11-digit product format
636297766
Labeler code
63629
Product ID
63629-7766_12559602-c87a-4726-8e38-cf5cfcc93b82
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine and pseudoephedrine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076557
Marketing category
ANDA
Marketing start
2004-11-17
Marketing end
0000-00-00
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], 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
63629-7766-1636297766015 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7766-1) 2021-12-220000-00-00NoNoCurrent
63629-7766-26362977660210 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7766-2) 2018-06-190000-00-00NoNoCurrent
63629-7766-36362977660314 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7766-3) 2019-11-120000-00-00NoNoCurrent