Fexofenadine HCl and Pseudoephedrine HCI

Product NDC
49035-273
11-digit product format
490350273
Labeler code
49035
Product ID
49035-273_89a65237-243f-d6ec-f917-07450a7670b2
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Wal-mart Stores Inc.
Application
ANDA076667
Marketing category
ANDA
Marketing start
2019-12-31
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-273-20EA - Each49035-2731e11a712-53a0-4c4e-a847-993137cfffca12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-273FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WAL-MART STORES INC.]6Legacy NDC20241031_1cbd3321-94c4-8c49-c520-6767aefe03ea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-273-20490350273204 BLISTER PACK in 1 CARTON (49035-273-20) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-12-310000-00-00NoNoCurrent
49035-273-30490350273306 BLISTER PACK in 1 CARTON (49035-273-30) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2019-12-310000-00-00NoNoCurrent