FDA.reportPublic FDA data

good sense aller ease

Product NDC
0113-0847
11-digit product format
001130847
Labeler code
0113
Product ID
0113-0847_5cd21fe5-5a25-4beb-a480-924996e65ee1
Type
HUMAN OTC DRUG
Nonproprietary name
fexofenadine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA212971
Marketing category
ANDA
Marketing start
2021-09-10
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense aller ease
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0847-00good sense aller ease150 in 1 BOTTLETABLET, FILM COATED1503
0113-0847-22good sense aller ease15 in 1 CARTONTABLET, FILM COATED153
0113-0847-22good sense aller ease1 in 1 BLISTER PACKTABLET, FILM COATED13
0113-0847-39good sense aller ease1 in 1 CARTONTABLET, FILM COATED13
0113-0847-39good sense aller ease30 in 1 BOTTLETABLET, FILM COATED303
0113-0847-47good sense aller ease1 in 1 CARTONTABLET, FILM COATED13
0113-0847-95good sense aller ease1 in 1 CARTONTABLET, FILM COATED13
0113-0847-95good sense aller ease45 in 1 BOTTLETABLET, FILM COATED453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0847-22EA - Each0113-08478e3e24c2-9975-4a06-aba2-3b626b10c93512024-02-14
0113-0847-39EA - Each0113-08473ed7e6de-30ad-4d48-9c00-d143a2d4c42212023-01-09
0113-0847-95EA - Each0113-08476cc1f1d1-b5e9-4773-815f-ab018ef2d56812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0847GOOD SENSE ALLER EASE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 8 package rows20250406_e533a008-b437-401e-ab50-bda31e6662d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNe533a008-b437-401e-ab50-bda31e6662d33
997420fexofenadine hydrochloride 180 MG Oral TabletSCDe533a008-b437-401e-ab50-bda31e6662d33
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYe533a008-b437-401e-ab50-bda31e6662d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0847-0000113084700150 in 1 BOTTLEHistorical
0113-0847-220011308472215 BLISTER PACK in 1 CARTON (0113-0847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK15 blister pack2021-09-140000-00-00NoNoCurrent
0113-0847-39001130847391 BOTTLE in 1 CARTON (0113-0847-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-100000-00-00NoNoCurrent
0113-0847-47001130847471 BOTTLE in 1 CARTON (0113-0847-47) / 150 TABLET, FILM COATED in 1 BOTTLE (0113-0847-00) 1 bottle2025-08-21NoNoCurrent
0113-0847-95001130847951 BOTTLE in 1 CARTON (0113-0847-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-140000-00-00NoNoCurrent