fexofenadine hcl

Product NDC: 71399-8659
11-digit product format: 713998659
Labeler code: 71399
Product ID: 71399-8659_48c50815-5149-7bba-e063-6294a90a714d
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hcl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AKRON PHARMA INC
Application: ANDA204507
Marketing category: ANDA
Marketing start: 2014-12-26
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2015-09-16
A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2015-09-16
A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2015-09-16
A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2015-09-16

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 5 · 172 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	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: fexofenadine hcl
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S068B75ZU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997501	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe67f0f1-c6f1-424e-8226-19176de79945	Available on FDA.report

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
71399-8659-1	2023-02-28	C162847	48780-1	f386c64a-27a1-0266-e053-dadaa90a7c1a	fe67f0f1-c6f1-424e-8226-19176de79945
71399-8659-1	2023-01-30	C162847	48780-1	f386c64a-27a1-0266-e053-dadaa90a7c1a	fe67f0f1-c6f1-424e-8226-19176de79945

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71399-8659-1	fexofenadine hcl	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
71399-8659-5	fexofenadine hcl	500 in 1 BOTTLE	TABLET, FILM COATED	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71399-8659-1	EA - Each	71399-8659	ec65a1bd-e066-474c-9ba3-4bf7bf1467f6	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71399-8659	FEXOFENADINE HCL TABLET, FILM COATED [AKRON PHARMA INC]	3	Current NDC, Legacy NDC, 2 package rows	20240221_fe67f0f1-c6f1-424e-8226-19176de79945.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	dd0da52b-fc82-4ec9-854c-0d7c52e926fb	2026-08-03	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Allergy Relief	FEXOFENADINE HCL	P & L Development, LLC	35b807b5-2e7a-446b-b378-eb5391ddfd14	2026-07-22	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Curist Hives Relief	FEXOFENADINE HYDROCHLORIDE 180 MG	Little Pharma, Inc.	04c75e93-b1f4-2546-e063-6394a90af0e1	2026-07-15	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Gencare-Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	a8595b29-1ea3-44aa-b131-030f34f408fc	2026-06-22	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Allergy Relief	FEXOFENADINE HCL	P & L Development, LLC	a976ad95-33d2-49f5-bad5-e980bf764879	2026-06-08	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	YYBA CORP	2dd5e6b0-2445-4419-b0e6-c62aadee6ea4	2026-03-18	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
fexofenadine hcl	FEXOFENADINE HCL	AKRON PHARMA INC	fe67f0f1-c6f1-424e-8226-19176de79945	2026-01-19	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507 ndc (product): 71399-8659
Fexofenadine Hydrochloride	FEXOFENADINE HCL	Northwind Health Company, LLC	f2b6c157-1af1-8d43-e053-2995a90aaf1a	2026-01-01	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	YYBA CORP	a1e80757-346f-4d88-8da7-55583c3a902b	2025-11-26	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
fexofenadine hcl	FEXOFENADINE HCL	Bryant Ranch Prepack	c23ad304-a5de-454e-a135-4eb143af2381	2025-10-22	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
IAllergy Relief	FEXOFENADINE HCL	Safeway, Inc.	1f6a97e3-f84a-4c89-8e8f-6e0d111fe500	2025-08-19	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
fexofenadine hcl	FEXOFENADINE HCL	Major Pharmaceuticals	107f398c-f296-4190-8234-82556a039e65	2025-08-12	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Fexofenadine Hydrochloride	FEXOFENADINE HCL	Major Pharmaceuticals	c34cda59-8a63-48ab-a19d-c06a1878f5da	2025-07-18	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Allergy Relief non drowsy	FEXOFENADINE HCL	MEIJER, INC.	b3395454-65db-4d8b-abce-2475b049a114	2025-07-02	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
fexofenadine hcl	FEXOFENADINE HCL	Aphena Pharma Solutions - Tennessee, LLC	34918a5a-c4c9-bc79-e063-6294a90acb85	2025-05-13	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
ALLERGY RELIEF	FEXOFENADINE HCL	Bi-Mart	ea8d8e12-4781-4501-a887-e732295d33bf	2025-04-28	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
fexofenadine hcl	FEXOFENADINE HCL	Aphena Pharma Solutions - Tennessee, LLC	31e71ee7-c4b5-6c1c-e063-6294a90a1513	2025-04-03	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
fexofenadine hcl	FEXOFENADINE HCL	Radha Pharmaceuticals	30283df1-6394-3a91-e063-6394a90a6776	2025-03-10	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
fexofenadine hcl	FEXOFENADINE HCL	ScieGen Pharmaceuticals, Inc.	b7e9477d-33d9-4463-b8a6-69af5f71ce35	2024-12-24	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	SPIRIT PHARMACEUTICALS LLC	5307b7ef-0c22-4aae-a2f6-033d31032f55	2024-12-13	Warnings	Exact identifier application applno (ANDA): 204507 application number: ANDA204507

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
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	fe67f0f1-c6f1-424e-8226-19176de79945	4
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	fe67f0f1-c6f1-424e-8226-19176de79945	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71399-8659-1	71399865901	100 TABLET, FILM COATED in 1 BOTTLE (71399-8659-1)	2021-11-01	0000-00-00	No	No	Current
71399-8659-5	71399865905	500 TABLET, FILM COATED in 1 BOTTLE (71399-8659-5)	2024-02-02		No	No	Current