FDA.reportPublic FDA data

Fexofenadine HCl and Pseudoephedrine HCl

Product NDC
51316-018
11-digit product format
513160018
Labeler code
51316
Product ID
51316-018_132629da-7f70-439b-3df7-876d0aeb01ee
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCl
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
ANDA079043
Marketing category
ANDA
Marketing start
2022-11-30
Marketing end
2026-08-31
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
180; 240 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine HCl and Pseudoephedrine HCl

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU, 6V9V2RYJ8N
Rxcui997415

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51316-018-10EA - Each51316-0185e0ec218-9e54-4673-969c-38428951ddcb12023-04-07
51316-018-15EA - Each51316-018e5ca728a-d0a8-400b-9c28-552fd38b8bd912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-018FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [CVS PHARMACY, INC]3Current NDC, Legacy NDC20240131_3a878985-3a0e-1960-db0e-e3b8fd9d5c63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997415fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN3a878985-3a0e-1960-db0e-e3b8fd9d5c635
99741524 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD3a878985-3a0e-1960-db0e-e3b8fd9d5c635
997415fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY3a878985-3a0e-1960-db0e-e3b8fd9d5c635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-018-10513160018102 BLISTER PACK in 1 CARTON (51316-018-10) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2022-11-302026-08-31NoNoCurrent
51316-018-15513160018153 BLISTER PACK in 1 CARTON (51316-018-15) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2022-11-302026-08-31NoNoCurrent