Fexofenadine HCL

Product NDC: 68071-2682
11-digit product format: 680712682
Labeler code: 68071
Product ID: 68071-2682_df39b1fc-200f-1720-e053-2a95a90a664e
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCL
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA204097
Marketing category: ANDA
Marketing start: 2019-02-18
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#

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2682		I	Inactivated by FDA		2026-09-14
excluded package	package	68071-2682	68071-2682-3	I	Inactivated by FDA		2026-09-14

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2682-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2682-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2682-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2682-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2682-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2682-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2682-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2682-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2682-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204097-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2016-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204097-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2016-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204097-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2016-08-19	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2682-3	2025-01-30	C162847	48780-1	2cef2736-7e94-d83d-e063-dadaa90ab31f	Fexofenadine Hydrochloride Tablets USP, 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2682-3	Fexofenadine HCL	1 in 1 CARTON	TABLET	1		2
68071-2682-3	Fexofenadine HCL	30 in 1 BOTTLE	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2682	FEXOFENADINE HCL TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 2 package rows	20220518_ddbe1423-5fd3-5334-e053-2995a90a9472.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	ddbe1423-5fd3-5334-e053-2995a90a9472	2
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	ddbe1423-5fd3-5334-e053-2995a90a9472	2
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	ddbe1423-5fd3-5334-e053-2995a90a9472	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2682-3	68071268203	1 BOTTLE in 1 CARTON (68071-2682-3) > 30 TABLET in 1 BOTTLE	1 bottle	2022-04-28	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.	2022-05-17	HUMAN OTC DRUG LABEL	2