Loratadine and Pseudoephedrine Sulfate

Product NDC
70518-0371
11-digit product format
705180371
Labeler code
70518
Product ID
70518-0371_e77650e2-918a-b3b9-e053-2995a90ae2e1
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine and Pseudoephedrine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076557
Marketing category
ANDA
Marketing start
2017-03-29
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0371-07051803710015 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-0371-0) 2017-03-290000-00-00NoNoCurrent
70518-0371-1705180371015 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0371-1) 2017-04-120000-00-00NoNoCurrent