Fexofenadine Hydrochloride

Product NDC: 62207-623
11-digit product format: 622070623
Labeler code: 62207
Product ID: 62207-623_1d43d4d6-9021-eac7-e063-6294a90ad21a
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Granules India Limited
Application: ANDA211075
Marketing category: ANDA
Marketing start: 2024-01-02
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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
unfinished product	product	62207-623		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	62207-623	62207-623-97	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

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 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`a67488948f0b…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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

Additional Listing Data#

Finished product: Yes
Brand name base: Fexofenadine Hydrochloride
Listing expiration: 2026-12-31

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
1d46555d-827b-b154-e063-6294a90ad3d5	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
62207-623-41	Fexofenadine Hydrochloride	24 in 1 CONTAINER	TABLET	24	1
62207-623-45	Fexofenadine Hydrochloride	225 in 1 CONTAINER	TABLET	225	1
62207-623-57	Fexofenadine Hydrochloride	90 in 1 CONTAINER	TABLET	90	1
62207-623-71	Fexofenadine Hydrochloride	7 in 1 CARTON	TABLET	7	1
62207-623-71	Fexofenadine Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62207-623	FEXOFENADINE HYDROCHLORIDE TABLET [GRANULES INDIA LIMITED]	1	Current NDC, 5 package rows	20240810_1d46555d-827b-b154-e063-6294a90ad3d5.zip

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	1d46555d-827b-b154-e063-6294a90ad3d5	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	1d46555d-827b-b154-e063-6294a90ad3d5	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	1d46555d-827b-b154-e063-6294a90ad3d5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62207-623-41	62207062341	24 TABLET in 1 CONTAINER (62207-623-41)	24 tablet	2024-01-02	No	No	Current
62207-623-45	62207062345	225 TABLET in 1 CONTAINER (62207-623-45)	225 tablet	2024-01-02	No	No	Current
62207-623-57	62207062357	90 TABLET in 1 CONTAINER (62207-623-57)	90 tablet	2024-01-02	No	No	Current
62207-623-71	62207062371	7 BLISTER PACK in 1 CARTON (62207-623-71) / 10 TABLET in 1 BLISTER PACK	7 blister pack	2024-01-02	No	No	Current
62207-623-97	62207062397	40000 TABLET in 1 DRUM (62207-623-97)	40000 tablet	27-NOV-23			Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl Tablets USP, 60 mg and 180 mg	Granules India Limited	2024-08-08	HUMAN OTC DRUG LABEL	1
Fexofenadine HCl Tablets USP, 180 mg (Gel Caps)	Granules India Limited	2023-12-05	BULK INGREDIENT	2