FDA.reportPublic FDA data

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC
56062-999
11-digit product format
560620999
Labeler code
56062
Product ID
56062-999_250de750-13e2-4bc2-b7a4-118c94f4162e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PUBLIX SUPER MARKETS INC
Application
ANDA090818
Marketing category
ANDA
Marketing start
2019-04-01
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56062-999-302021-01-29C16284748780-1ba0f9c33-4524-a910-e053-dadaa90a0b85Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, 60 mg/120 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-999-30Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE302
56062-999-30Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-999FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC]2Legacy NDC, 2 package rows20190529_728f8a1f-7dd7-4991-8b30-cccf7be32185.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN728f8a1f-7dd7-4991-8b30-cccf7be321852
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD728f8a1f-7dd7-4991-8b30-cccf7be321852
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY728f8a1f-7dd7-4991-8b30-cccf7be321852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
56062-999-305606209993030 in 1 BLISTER PACKHistorical