FDA.reportPublic FDA data

Fexofenadine HCl

Product NDC
69230-202
11-digit product format
692300202
Labeler code
69230
Product ID
69230-202_09845f21-f05e-34b2-e063-6394a90a7677
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Consumer Care
Application
ANDA204507
Marketing category
ANDA
Marketing start
2015-09-16
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
Fexofenadine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU
Rxcui997420, 997501

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69230-202-012021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-052021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-112021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-302021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-452021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-602021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-902021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-012020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-052020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-112020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-302020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-452020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-602020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-902020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69230-202-01Fexofenadine HCl100 in 1 BOTTLETABLET, FILM COATED1003
69230-202-01Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-05Fexofenadine HCl500 in 1 BOTTLETABLET, FILM COATED5003
69230-202-11Fexofenadine HCl1000 in 1 BOTTLETABLET, FILM COATED10003
69230-202-30Fexofenadine HCl30 in 1 BOTTLETABLET, FILM COATED303
69230-202-30Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-45Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-45Fexofenadine HCl45 in 1 BOTTLETABLET, FILM COATED453
69230-202-60Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-60Fexofenadine HCl60 in 1 BOTTLETABLET, FILM COATED603
69230-202-90Fexofenadine HCl90 in 1 BOTTLETABLET, FILM COATED903
69230-202-90Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-202-01EA - Each69230-20283484e5c-4840-461c-91cb-f7f8b309cbd612018-02-20
69230-202-30EA - Each69230-2020bfc5135-5b54-4d96-b2ed-9bdac16e063712018-02-20
69230-202-60EA - Each69230-2024e8881ff-d9f4-4224-b74c-f9ef0e3d3e4b12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-202FEXOFENADINE HCL TABLET, FILM COATED [CAMBER CONSUMER CARE]3Current NDC, Legacy NDC, 12 package rows20231108_1bb1bea3-b17d-4326-b037-7468add0df80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN53beda1f-3aa1-4ba9-ae70-d69b6fbe4ebc18
997420fexofenadine hydrochloride 180 MG Oral TabletSCD53beda1f-3aa1-4ba9-ae70-d69b6fbe4ebc18
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY53beda1f-3aa1-4ba9-ae70-d69b6fbe4ebc18
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1bb1bea3-b17d-4326-b037-7468add0df803
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN3b147968-c6a8-4725-89b6-2eb443900e8f3
997501fexofenadine HCl 60 MG Oral TabletPSN1bb1bea3-b17d-4326-b037-7468add0df803
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1bb1bea3-b17d-4326-b037-7468add0df803
997420fexofenadine hydrochloride 180 MG Oral TabletSCD3b147968-c6a8-4725-89b6-2eb443900e8f3
997501fexofenadine hydrochloride 60 MG Oral TabletSCD1bb1bea3-b17d-4326-b037-7468add0df803
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1bb1bea3-b17d-4326-b037-7468add0df803
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY3b147968-c6a8-4725-89b6-2eb443900e8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-202-01692300202011 BOTTLE in 1 CARTON (69230-202-01) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-160000-00-00NoNoCurrent
69230-202-0569230020205500 TABLET, FILM COATED in 1 BOTTLE (69230-202-05) 2015-09-160000-00-00NoNoCurrent
69230-202-11692300202111000 TABLET, FILM COATED in 1 BOTTLE (69230-202-11) 2015-09-160000-00-00NoNoCurrent
69230-202-30692300202301 BOTTLE in 1 CARTON (69230-202-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-160000-00-00NoNoCurrent
69230-202-45692300202451 BOTTLE in 1 CARTON (69230-202-45) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-160000-00-00NoNoCurrent
69230-202-60692300202601 BOTTLE in 1 CARTON (69230-202-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-160000-00-00NoNoCurrent
69230-202-90692300202901 BOTTLE in 1 CARTON (69230-202-90) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-160000-00-00NoNoCurrent