FDA.reportPublic FDA data

ALLERGY 24-HR

Product NDC
64679-987
Requested package NDC
64679-987-05
11-digit product format
646790987
Labeler code
64679
Product ID
64679-987_f0f5c363-88c5-7177-e053-2a95a90a1a78
Type
HUMAN OTC DRUG
Nonproprietary name
FEXOFENADINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA079112
Marketing category
ANDA
Marketing start
2012-02-08
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64679-98764679-987-05DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2012-02-08
A079112-003FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2012-02-08
A079112-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08
A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2012-02-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079112-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2012-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079112-006FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2012-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079112-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2012-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079112-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2012-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079112-003FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2012-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079112-004FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2012-02-082680178bc6a6…

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
64679-987-052025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-102025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-112025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-142025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-172025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-202025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-222025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-242025-12-12C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-052024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-102024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-112024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-142024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-172024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-202024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-222024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-242024-01-30C16284748780-11030e365-3768-111a-e063-dadaa90a10e2ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-082020-01-31C16284748780-19d75b9d1-1adf-f424-e053-dadaa90a57ceFexofenadine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64679-987-07Fexofenadine5 in 1 BLISTER PACKTABLET, FILM COATED51
64679-987-08Fexofenadine1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-987-09EA - Each64679-987a99e9d5d-19a7-4aef-9f24-6195937041c512015-06-09
64679-987-10EA - Each64679-98718963b59-d80d-44ac-8692-7f082dd65e4312015-06-09
64679-987-11EA - Each64679-987ef2c085c-61ce-4dfc-9320-f02f47381b9112015-06-09
64679-987-12EA - Each64679-98799dbc750-13a9-42b0-85b7-a995830794f812015-06-09
64679-987-13EA - Each64679-987021e3a5d-fc06-4e43-9a62-a9afe30feb0312015-06-09
64679-987-16EA - Each64679-98719834fc4-eb77-40ea-b275-f3bbba76485e12019-07-02
64679-987-17EA - Each64679-98722a99016-8654-4ff0-9b21-a0a527bacb4812016-03-04
64679-987-20EA - Each64679-987f05034d8-bd1e-435e-913b-edfbc159f33612016-03-04
64679-987-24EA - Each64679-98787da958d-cb9f-406e-988f-f65346a5b79412016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-987ALLERGY 24-HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WOCKHARDT USA LLC.]8Legacy NDC20221230_f4b394a6-8b4d-41ac-8962-82e81d85dd90.zip
64679-987FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.]1Legacy NDC, 2 package rows20120404_9a5da651-483e-4e51-b822-12465930fa5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN9a5da651-483e-4e51-b822-12465930fa5c1
997488fexofenadine HCl 30 MG Oral TabletPSN9a5da651-483e-4e51-b822-12465930fa5c1
997501fexofenadine HCl 60 MG Oral TabletPSN9a5da651-483e-4e51-b822-12465930fa5c1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD9a5da651-483e-4e51-b822-12465930fa5c1
997488fexofenadine hydrochloride 30 MG Oral TabletSCD9a5da651-483e-4e51-b822-12465930fa5c1
997501fexofenadine hydrochloride 60 MG Oral TabletSCD9a5da651-483e-4e51-b822-12465930fa5c1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY9a5da651-483e-4e51-b822-12465930fa5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-987-05646790987052000 TABLET, FILM COATED in 1 POUCH (64679-987-05) 2012-02-080000-00-00NoNoCurrent