FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
72789-196
11-digit product format
727890196
Labeler code
72789
Product ID
72789-196_40ac042c-0bf7-c7f4-e063-6294a90a4094
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
72789-196-10Fexofenadine HCL10 in 1 BOTTLE, PLASTICTABLET109
72789-196-30Fexofenadine HCL30 in 1 BOTTLE, PLASTICTABLET309
72789-196-90Fexofenadine HCL90 in 1 BOTTLE, PLASTICTABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-196-10EA - Each72789-196774388b3-587e-4576-8a98-6c9731aea95b12023-04-07
72789-196-30EA - Each72789-19613969256-4510-4e23-98e5-2998857f042b12022-10-06
72789-196-90EA - Each72789-1966cf5b51e-42b4-4bb5-8d33-b70823cd91f412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-196FEXOFENADINE HCL TABLET [PD-RX PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 3 package rows20241011_07460764-43fa-49fd-ae77-d4571cb9f944.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-196-107278901961010 TABLET in 1 BOTTLE, PLASTIC (72789-196-10) 10 tablet2023-03-14NoNoCurrent
72789-196-307278901963030 TABLET in 1 BOTTLE, PLASTIC (72789-196-30) 30 tablet2022-09-150000-00-00NoNoCurrent
72789-196-907278901969090 TABLET in 1 BOTTLE, PLASTIC (72789-196-90) 90 tablet2021-07-060000-00-00NoNoCurrent