Fexofenadine Hydrochloride

Product NDC: 73629-008
11-digit product format: 736290008
Labeler code: 73629
Product ID: 73629-008_47d41023-701b-09eb-e063-6294a90a7298
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AMZ789 LLC
Application: ANDA211075
Marketing category: ANDA
Marketing start: 2024-07-27
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: 2027-12-31
Current FDA listing: Yes

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

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 2 · 78 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	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…`
2022-03-09 01:35 UTC	2022-03	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`782e0a99824c…`

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	180 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
997420	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
1e46343f-d6b6-73ba-e063-6394a90acd94	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	Strength	SPL version
73629-008-03	Fexofenadine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73629-008	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AMZ789 LLC]	1	Current NDC, 1 package rows	20240830_1e46343f-d6b6-73ba-e063-6394a90acd94.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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	FEXOFENADINE HCL	Family Dollar (FAMILY WELLNESS)	9d33bc80-696c-4f21-b38d-2cad0c1f09ad	2026-07-09	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CVS PHARMACY	c77ee2bb-dc95-d8c9-e053-2995a90a9602	2026-07-08	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HCL	WALMART INC. (see also Equate)	eb37cf76-49e2-4332-b449-1ce475556ef5	2026-07-08	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Ltd	3151bc6d-b40b-4200-a5cf-e57b6791d92a	2026-06-15	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Granules India Limited	e0537b71-fdee-4122-9c09-868ce7352080	2026-06-15	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HCL	FSA Store Inc. (Caring Mills)	d33f15db-0e5e-4515-b7a7-cb2760469ac1	2026-06-11	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	YYBA Corp	53e87aa4-9db3-9ded-e063-6294a90a319e	2026-06-10	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Grocery Outlet, Inc.	441ce66e-515a-d380-e063-6394a90aec7d	2026-05-21	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	895de6e9-c5b6-42fe-b450-f5d8331ce2e3	2026-05-21	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCl 180 mg	FEXOFENADINE HCL	Farmacias De Similares TX LLC	49753406-729b-e48f-e063-6394a90a722a	2026-04-08	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HCL	Safeway, Inc.	a29e33ac-77f7-4e06-b6f1-82ecaa919cad	2026-01-26	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HYVEE INC	3e61ffb1-1c52-1ad5-e063-6294a90a6e3f	2026-01-13	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	AMZ789 LLC	1e46343f-d6b6-73ba-e063-6394a90acd94	2026-01-07	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075 ndc (product): 73629-008
Fexofenadine HCL	FEXOFENADINE HCL	Safeway, Inc	f32e9cb6-af93-e60a-e053-2995a90a42f5	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	Meijer, Inc.	16de2c5d-b27b-9fb4-e063-6394a90a8390	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	Meijer	181c7faf-b27d-0a2d-e063-6294a90ad1f4	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	TARGET CORPORATION	fdb8451b-fba3-c7ca-e053-6294a90a05d7	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	Walgreens	fd775af1-782e-bb4f-e053-6294a90aaa5d	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	CVS	00ef8467-30a0-7579-e063-6294a90a75af	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211075 application number: ANDA211075
Fexofenadine HCL	FEXOFENADINE HCL	CVS	013ef192-5184-b720-e063-6394a90a98c4	2025-12-19	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	1e46343f-d6b6-73ba-e063-6394a90acd94	2
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	1e46343f-d6b6-73ba-e063-6394a90acd94	2
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	1e46343f-d6b6-73ba-e063-6394a90acd94	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73629-008-03	73629000803	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73629-008-03)	2024-07-27	No	No	Current