Pseudoephedrine hydrochloride

Product NDC
70518-3405
11-digit product format
705183405
Labeler code
70518
Product ID
70518-3405_dc270f0e-066d-6853-e053-2a95a90ae6b8
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077442
Marketing category
ANDA
Marketing start
2022-04-07
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3405-07051834050010 TABLET, FILM COATED in 1 BLISTER PACK (70518-3405-0) 2022-04-070000-00-00NoNoCurrent