Allergy Relief

Product NDC
49035-784
11-digit product format
490350784
Labeler code
49035
Product ID
49035-784_de31cca4-2953-4ad4-34a4-a532f0f8a286
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
Application
ANDA076502
Marketing category
ANDA
Marketing start
2011-04-13
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-784DDiscontinued by firm2026-08-03
excluded packagepackage49035-78449035-784-29DDiscontinued by firm2026-08-03
excluded packagepackage49035-78449035-784-30DDiscontinued by firm2026-08-03
excluded packagepackage49035-78449035-784-43DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-784-29d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-784-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-784-43d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-784-29f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-784-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-784-43f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-784-432ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-784-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-784-292ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-784-43a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-784-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-784-29a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-784-43cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-784-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-784-29cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-784-43cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-784-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-784-29cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-784-43302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-784-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-784-29302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-784-43ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-784-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-784-29ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-784-430efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-784-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-784-290efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-784-43ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-784-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-784-29ad56d346431e…cc804d4bbf1e…

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

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076502-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-11
A076502-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-11
A076502-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-11
A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12
A076502-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12

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 10 · 369 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076502-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076502-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076502-001AB18072bd15b7f6…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fexofenadine HydrochlorideACTIVE INGREDIENT2S068B75ZUALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
mannitolINACTIVE INGREDIENT3OWL53L36AALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-784ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [WAL-MART STORES, INC.]4Legacy NDC20241101_6ab3b3a1-e91b-7167-c9d2-0cde42edcb73.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEBluePoint Laboratoriesa86aebd0-937e-5d73-e053-2995a90a656a2026-07-13WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Limited864e3052-5787-bf11-9d17-11274ca2304f2026-07-09WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.b0121213-eae1-8429-9986-3b3b26f35e472026-07-09WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Non-Drowsy Allergy ReliefFEXOFENADINE HYDROCHLORIDETARGET CORPORATION3cf4b7fe-b1f7-b767-430a-655408f917532025-08-01WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEMAJOR PHARMACEUTICALS0a6da401-a8a3-5d0b-f37e-c220838f7e492025-07-27WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEWalgreens Companyb961985e-0c18-b36f-d82e-32ff2d46fada2025-07-18WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDollar General1b2a14a1-a5cc-4f5e-8127-57e9d913f50a2024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEKROGER COMPANY7b146260-c925-3238-d092-24b7101ceb502024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.624b3a91-af4f-8848-6fc3-392e0df34cc82024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Health Corp.204506d7-7688-fd7e-0aae-142b698848ef2024-11-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEStrategic Sourcing Services, LLCde438313-9790-b4ea-2d28-7a19836cf5e22023-04-21WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Allergy ReliefFEXOFENADINE HYDROCHLORIDERite Aid Corporationaf2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce2022-06-12WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Wal-FexFEXOFENADINE HYDROCHLORIDEWalgreens Company95d420ea-6337-304f-54c3-0c75be1608e22022-01-22WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Allergy ReliefFEXOFENADINE HYDROCHLORIDEFamily Dollar Stores, Inc.f532e9d5-6457-8bef-e83e-16050f20b03c2020-02-19WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESam's West Inc.1c1f43c4-7128-37c4-83fe-7eefac3fd4772019-10-07WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Allergy ReliefFEXOFENADINE HYDROCHLORIDESafeway Inc3c30a1dc-a13d-2522-d4d0-00c1e9dbab072017-12-11WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEChain Drug Consortium, LLCd1d8d0ec-2bdd-fb07-a051-d6353e3c240c2014-01-22WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEChain Drug Marketing Associate8a1de8a1-808a-bc08-6c74-957d6f388eab2014-01-22WarningsExact identifier
application applno (ANDA): 076502
application number: ANDA076502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-784-29490350784293 BLISTER PACK in 1 CARTON (49035-784-29) > 5 TABLET in 1 BLISTER PACK3 blister pack2011-04-130000-00-00NoNoCurrent
49035-784-30490350784301 BOTTLE in 1 CARTON (49035-784-30) > 30 TABLET in 1 BOTTLE1 bottle2011-04-130000-00-00NoNoCurrent
49035-784-43490350784432 BOTTLE in 1 CARTON (49035-784-43) > 30 TABLET in 1 BOTTLE2 bottle2011-04-130000-00-00NoNoCurrent