FEXOFENADINE HYDROCHLORIDE

Product NDC: 62756-543
Requested package NDC: 62756-543-88
11-digit product format: 627560543
Labeler code: 62756
Product ID: 62756-543_754f554d-91c6-4314-870c-b87e9a386153
Type: HUMAN OTC DRUG
Nonproprietary name: FEXOFENADINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA091567
Marketing category: ANDA
Marketing start: 2012-02-06
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 60 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62756-543	62756-543-88	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

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

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

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-06
A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-06
A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-06
A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-06
A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-06
A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-06

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`2680178bc6a6…`

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, Related label table
NDC	Related label
62756-543-64	Fexofenadine Hydrochloride Tablets, USP
62756-543-66	Fexofenadine Hydrochloride Tablets, USP
62756-543-74	Fexofenadine Hydrochloride Tablets, USP
62756-543-76	Fexofenadine Hydrochloride Tablets, USP
62756-543-77	Fexofenadine Hydrochloride Tablets, USP
62756-543-78	Fexofenadine Hydrochloride Tablets, USP
62756-543-83	Fexofenadine Hydrochloride Tablets, USP
62756-543-88	Fexofenadine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62756-543-64	FEXOFENADINE HYDROCHLORIDE	5 in 1 CARTON	TABLET, FILM COATED	5	6
62756-543-64	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-543-66	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-543-66	FEXOFENADINE HYDROCHLORIDE	2 in 1 CARTON	TABLET, FILM COATED	2	6
62756-543-74	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-543-74	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	6
62756-543-76	FEXOFENADINE HYDROCHLORIDE	10 in 1 CARTON	TABLET, FILM COATED	10	6
62756-543-76	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-543-77	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-543-77	FEXOFENADINE HYDROCHLORIDE	9 in 1 CARTON	TABLET, FILM COATED	9	6
62756-543-78	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-543-78	FEXOFENADINE HYDROCHLORIDE	15 in 1 CARTON	TABLET, FILM COATED	15	6
62756-543-83	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
62756-543-88	FEXOFENADINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-543	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Legacy NDC, 14 package rows	20181026_04923af6-97fc-4e32-834d-1df643832d7f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	58193632-2468-4159-b1a9-c24a489f199f	2026-06-24	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	OHM LABORATORIES INC.	1a1afa95-570d-456e-b436-a0fcfaf68517	2026-05-05	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	CVS PHARMACY, INC	7bc13851-291a-4582-8261-13c5022fbdd1	2024-05-24	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	AMERISOURCE BERGEN	2a578643-adc1-44ca-83f2-9d48527bd3a4	2024-05-14	Warnings	Exact identifier application applno (ANDA): 091567 application number: ANDA091567

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	04923af6-97fc-4e32-834d-1df643832d7f	6
997488	fexofenadine HCl 30 MG Oral Tablet	PSN	04923af6-97fc-4e32-834d-1df643832d7f	6
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	04923af6-97fc-4e32-834d-1df643832d7f	6
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	04923af6-97fc-4e32-834d-1df643832d7f	6
997488	fexofenadine hydrochloride 30 MG Oral Tablet	SCD	04923af6-97fc-4e32-834d-1df643832d7f	6
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	04923af6-97fc-4e32-834d-1df643832d7f	6
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	04923af6-97fc-4e32-834d-1df643832d7f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-543-88	62756054388	100 TABLET, FILM COATED in 1 BOTTLE (62756-543-88)	2012-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride Tablets, USP	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2018-10-26	Human OTC Drug Label	6