FDA.reportPublic FDA data

Fexofenadine HCL

Product NDC
70677-1256
11-digit product format
706771256
Labeler code
70677
Product ID
70677-1256_31168932-2ebb-7423-e063-6394a90a081f
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services
Application
ANDA204097
Marketing category
ANDA
Marketing start
2025-05-01
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
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1256-1Fexofenadine HCL1 in 1 CARTONTABLET11
70677-1256-1Fexofenadine HCL30 in 1 BOTTLETABLET301
70677-1256-2Fexofenadine HCL1 in 1 CARTONTABLET11
70677-1256-2Fexofenadine HCL500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1256-1EA - Each70677-1256214cf67b-4aaa-48c1-887b-a3b50de12a8712025-05-14
70677-1256-2EA - Each70677-12568722da54-5828-48f9-bf79-d14ca66854b812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1256FEXOFENADINE HCL (FEXOFENADINE HCL) TABLET [STRATEGIC SOURCING SERVICES]1Current NDC, 4 package rows20250501_722eda62-9204-400a-8db4-e4aba9cd443b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN722eda62-9204-400a-8db4-e4aba9cd443b1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD722eda62-9204-400a-8db4-e4aba9cd443b1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY722eda62-9204-400a-8db4-e4aba9cd443b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1256-1706771256011 BOTTLE in 1 CARTON (70677-1256-1) / 30 TABLET in 1 BOTTLE1 bottle2025-05-01NoNoHistorical
70677-1256-2706771256021 BOTTLE in 1 CARTON (70677-1256-2) / 500 TABLET in 1 BOTTLE1 bottle2025-05-01NoNoHistorical