pseudoephedrine hydrochloride

Product NDC
70518-1618
11-digit product format
705181618
Labeler code
70518
Product ID
70518-1618_d9b8e6ed-89da-182c-e053-2a95a90a936e
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075153
Marketing category
ANDA
Marketing start
2019-10-30
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1618-0705181618001 BLISTER PACK in 1 CARTON (70518-1618-0) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2018-10-300000-00-00NoNoCurrent