Fexofenadine HCL

Product NDC: 68071-4846
Requested package NDC: 68071-4846-9
11-digit product format: 680714846
Labeler code: 68071
Product ID: 68071-4846_bb8fff22-c6c7-4620-e053-2995a90ae117
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCL
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA204097
Marketing category: ANDA
Marketing start: 2016-08-19
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 180 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-4846	68071-4846-9	D	Discontinued by firm		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2016-08-19
A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2016-08-19
A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2016-08-19

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-14	Fexofenadine Hydrochloride Tablets USP, 180 mg
2023-01-30	Fexofenadine Hydrochloride Tablets USP, 180 mg
2021-02-17	Fexofenadine Hydrochloride Tablets USP, 180 mg
2021-01-29	Fexofenadine Hydrochloride Tablets USP, 180 mg

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCL	FEXOFENADINE HCL	Walmart Inc.	353323b7-67ce-7ce6-e063-6394a90a77d4	2026-07-21	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
equate allergy relief	FEXOFENADINE HYDROCHLORIDE	Walmart Inc.	852c8ad2-fc7d-4728-b2c6-f64b960fe2ab	2026-07-18	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Goodmeds Non Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	ae1322f5-85d6-4243-b384-2ce7f8c8d692	2026-04-20	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Preferred Pharmaceuticals, Inc.	67679801-a8fe-4038-be71-96e1312badab	2026-04-16	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
ValuMeds Non-Drowsy Allergy Relief Fexofenadine HCl	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	f9ccd673-c65f-45c6-9863-26136eb816db	2026-01-06	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Northwind Health Company, LLC	f7584431-11aa-8213-e053-6294a90a1585	2026-01-01	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	YYBA Corp	52d50976-e63a-b3e3-e063-6294a90a6a97	2026-01-01	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	PD-Rx Pharmaceuticals, Inc.	07460764-43fa-49fd-ae77-d4571cb9f944	2025-10-08	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
24HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	b72c4802-1bcb-48bc-b4b9-72167ea4643e	2025-06-12	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Strategic Sourcing Services	722eda62-9204-400a-8db4-e4aba9cd443b	2025-03-24	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Bryant Ranch Prepack	6bc92969-0d06-4bf5-a634-80964464546c	2024-08-23	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Allergy Relief	ALLERGY RELIEF	Allegiant Health	89ece1b5-7604-4dce-a8a6-df5b948e3cff	2024-04-17	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	Proficient Rx LP	f9a7e836-6055-484f-a197-181220428574	2024-03-01	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	A-S Medication Solutions	767b082e-915d-482f-8c6b-22b6e23bca19	2023-12-27	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	A-S Medication Solutions	b420b619-e643-43e6-9b8b-81af11fdd4ed	2023-12-15	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	A-S Medication Solutions	a96e6e63-3be9-4e89-ae45-b74b378997b1	2023-10-23	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Childrens Allergy Relief	FEXOFENADINE HCL	PLD Acquisitions LLC DBA Avma Pharma Solutions	052d6191-1d9c-45c9-8c81-d19a977eded5	2023-02-13	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Allergy Relief	FEXOFENADINE HCL	PLD Acquisitions LLC DBA Avma Pharma Solutions	0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f	2023-02-09	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Allergy Relief	FEXOFENADINE HCL	PLD Acquisitions LLC DBA Avma Pharma Solutions	9f1f292d-6d5f-4600-ad27-323e498ddecb	2023-02-09	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097
Fexofenadine HCL	FEXOFENADINE HCL	NorthStar RxLLC	9c308a91-640d-441b-8fb5-acb5a415405e	2019-04-30	Warnings	Exact identifier application applno (ANDA): 204097 application number: ANDA204097

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4846-9	68071484609	90 TABLET in 1 BOTTLE (68071-4846-9)	90 tablet	2019-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride Tablets USP, 180 mg	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN OTC DRUG LABEL	2