Fexofenadine Hydrochloride

Product NDC: 62207-889
11-digit product format: 622070889
Labeler code: 62207
Product ID: 62207-889_5447e2c4-49cb-5f8d-e063-6294a90a2457
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Granules India Limited
Application: ANDA211075
Marketing category: ANDA
Marketing start: 2023-11-07
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL			2019-10-18
A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2019-10-18

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 3 · 82 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	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`

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 Hydrochloride
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997420	Internal RxNorm lookup
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
e0537b71-fdee-4122-9c09-868ce7352080	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62207-889-49	Fexofenadine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	3
62207-889-51	Fexofenadine Hydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	3
62207-889-51	Fexofenadine Hydrochloride	10 in 1 BOTTLE	TABLET, FILM COATED	10	3
62207-889-60	Fexofenadine Hydrochloride	8 in 1 CARTON	TABLET, FILM COATED	8	3
62207-889-60	Fexofenadine Hydrochloride	9 in 1 BLISTER PACK	TABLET, FILM COATED	9	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62207-889	FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [GRANULES INDIA LIMITED]	2	Current NDC, 5 package rows	20231114_e0537b71-fdee-4122-9c09-868ce7352080.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 2 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCL	FEXOFENADINE HCL	CVS	013ef192-5184-b720-e063-6394a90a98c4	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	Walgreens	0eaf28a5-f8dd-3888-e063-6394a90a8cc6	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1dd9affe-b55d-e1fb-e063-6394a90a7794	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1dda06c9-8e0f-38d7-e063-6394a90aba3e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1ddad045-7706-ea7e-e063-6394a90a2a5a	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1ddae2a1-0e16-e294-e063-6394a90a05f5	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl	FEXOFENADINE HCL	Rite Aid	1ddb1716-9c5b-6348-e063-6394a90acbf1	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	GRANULES PHARMACEUTICALS INC.	fa30c8ce-ad9d-b6fe-e053-6294a90a2443	2025-12-04	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	9ed710e1-47f4-4d04-a509-12c8c97c192c	2025-11-05	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
ValuMeds 24-Hour Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	036f8eaa-7eb9-46f4-b42e-3c8c7e49e450	2025-10-23	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	5237c8bd-0b20-4639-a740-f3001c4c2c94	2025-10-22	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	FSA STORE INC.	276e9767-93c0-5932-e063-6394a90ab2d9	2025-03-07	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	Walgreens	fd7920f6-f53e-90cf-e053-6294a90aa8db	2024-12-16	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HARRIS TEETER	c4f9e849-f286-4167-e053-2a95a90a38f9	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG CONSORTIUM	8eee26c2-af58-469c-b855-c3bfc8bd7e2d	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	c5d58d74-da08-eb72-e053-2a95a90adc27	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	5059ffc9-b116-4d11-9678-56c696f4e3db	2024-08-16	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Limited	1d46555d-827b-b154-e063-6294a90ad3d5	2024-08-08	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	c547c163-2a19-10d8-e053-2a95a90ac817	2024-07-24	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway, Inc.	348b79cf-1184-46d4-a0e5-fdc24afec1a5	2024-02-09	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075

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	e0537b71-fdee-4122-9c09-868ce7352080	3
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	e0537b71-fdee-4122-9c09-868ce7352080	3
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	e0537b71-fdee-4122-9c09-868ce7352080	3
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	e0537b71-fdee-4122-9c09-868ce7352080	3
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	e0537b71-fdee-4122-9c09-868ce7352080	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62207-889-49	62207088949	1000 TABLET, FILM COATED in 1 BOTTLE (62207-889-49)		2023-11-07	No	No	Current
62207-889-51	62207088951	1 BOTTLE in 1 CARTON (62207-889-51) / 10 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2023-11-07	No	No	Current
62207-889-60	62207088960	8 BLISTER PACK in 1 CARTON (62207-889-60) / 9 TABLET, FILM COATED in 1 BLISTER PACK	8 blister pack	2023-11-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl Tablets USP, 60 mg and 180 mg	Granules India Limited \| GRANULES LIFE SCIENCES PRIVATE LIMITED	2026-06-15	HUMAN OTC DRUG LABEL	4