FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
16714-899
11-digit product format
167140899
Labeler code
16714
Product ID
16714-899_2d00700d-63a2-4a45-b607-028a883fe10a
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA204097
Marketing category
ANDA
Marketing start
2019-02-18
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-899-01Fexofenadine HCL30 in 1 BOTTLETABLET303
16714-899-01Fexofenadine HCL1 in 1 CARTONTABLET13
16714-899-02Fexofenadine HCL100 in 1 BOTTLETABLET1003
16714-899-02Fexofenadine HCL1 in 1 CARTONTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-899-01EA - Each16714-89968d66b2e-0c9c-4244-879c-b950a7997e2c12019-08-06
16714-899-02EA - Each16714-89977401375-1123-4070-ae19-c8a1cebe541112019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-899FEXOFENADINE HCL TABLET [NORTHSTAR RXLLC]3Current NDC, Legacy NDC, 4 package rows20190501_9c308a91-640d-441b-8fb5-acb5a415405e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN07460764-43fa-49fd-ae77-d4571cb9f9449
997420fexofenadine hydrochloride 180 MG Oral TabletSCD07460764-43fa-49fd-ae77-d4571cb9f9449
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY07460764-43fa-49fd-ae77-d4571cb9f9449
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN9c308a91-640d-441b-8fb5-acb5a415405e3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD9c308a91-640d-441b-8fb5-acb5a415405e3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY9c308a91-640d-441b-8fb5-acb5a415405e3
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSNddbe1423-5fd3-5334-e053-2995a90a94722
997420fexofenadine hydrochloride 180 MG Oral TabletSCDddbe1423-5fd3-5334-e053-2995a90a94722
997420fexofenadine HCl 180 MG 24 HR Oral TabletSYddbe1423-5fd3-5334-e053-2995a90a94722
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN767b082e-915d-482f-8c6b-22b6e23bca191
997420fexofenadine hydrochloride 180 MG Oral TabletSCD767b082e-915d-482f-8c6b-22b6e23bca191
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY767b082e-915d-482f-8c6b-22b6e23bca191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-899-01167140899011 BOTTLE in 1 CARTON (16714-899-01) / 30 TABLET in 1 BOTTLE1 bottle2019-02-180000-00-00NoNoCurrent
16714-899-02167140899021 BOTTLE in 1 CARTON (16714-899-02) / 100 TABLET in 1 BOTTLE1 bottle2019-02-180000-00-00NoNoCurrent