Fexofenadine HCl 180 mg

Product NDC
85786-204
11-digit product format
857860204
Labeler code
85786
Product ID
85786-204_4ef8be57-98e8-20a9-e063-6394a90ab779
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Farmacias De Similares TX LLC
Application
ANDA211075
Marketing category
ANDA
Marketing start
2026-04-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine HCl 180 mg
Listing expiration
2027-12-31

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
85786-204-30Fexofenadine HCl 180 mg30 in 1 BOTTLE, PLASTICTABLET302
85786-204-30Fexofenadine HCl 180 mg1 in 1 CARTONTABLET12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN49753406-729b-e48f-e063-6394a90a722a2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD49753406-729b-e48f-e063-6394a90a722a2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY49753406-729b-e48f-e063-6394a90a722a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85786-204-30857860204301 BOTTLE, PLASTIC in 1 CARTON (85786-204-30) / 30 TABLET in 1 BOTTLE, PLASTIC2026-04-08NoNoHistorical