FEXOFENADINE HYDROCHLORIDE

Product NDC: 68210-0122
11-digit product format: 682100122
Labeler code: 68210
Product ID: 68210-0122_ee27ea1a-c047-9030-e053-2995a90a131e
Type: HUMAN OTC DRUG
Nonproprietary name: FEXOFENADINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Spirit Pharmaceuticals LLC
Application: ANDA210137
Marketing category: ANDA
Marketing start: 2019-03-21
Marketing end: 0000-00-00
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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68210-0122		I	Inactivated by FDA	2026-08-17
excluded package	package	68210-0122	68210-0122-1	I	Inactivated by FDA	2026-08-17
excluded package	package	68210-0122	68210-0122-3	I	Inactivated by FDA	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2018-08-13

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`e64feba35796…`

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
68210-0122-1	2026-01-29	C162847	48780-1	49896155-ce8b-586f-e063-e6dba90add90	Valumeds FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg
68210-0122-3	2026-01-29	C162847	48780-1	49896155-ce8b-586f-e063-e6dba90add90	Valumeds FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-0122-1	FEXOFENADINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	8
68210-0122-3	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	8
68210-0122-3	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET	1	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-0122	FEXOFENADINE HYDROCHLORIDE TABLET [SPIRIT PHARMACEUTICALS LLC]	8	Legacy NDC, 3 package rows	20241215_c18f3207-92ad-4999-99c8-b51a1edcece3.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	YYBA Corp	53fe8ef5-ab65-f23e-e063-6394a90a30f0	2026-06-11	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
FEXOFENADINE HCl	FEXOFENADINE HCL	Strategic Sourcing Services, LLC	7a49f700-5892-404b-b81a-4a92c1928806	2026-01-29	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
Nuvicare Hives Relief	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	a8e11094-ca69-488d-a720-b8129f17f505	2026-01-21	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
Gencare Hives Relief	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	ad0944f1-c5af-42cf-96c9-3140cbda66d8	2026-01-21	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	d7fe71e4-aada-40f5-86a8-bf0d7eb9b851	2025-12-26	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	0a4f4178-bea5-4995-99dc-96980cccdc8a	2025-12-26	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	bb47b839-3f49-4818-a62c-b6d2b09b15dc	2025-12-19	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
CVS Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Pharmacy	3d6c7b10-ed05-bbde-e063-6294a90ae92f	2025-10-22	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	ec55732c-a3db-4445-a06d-0f98b21ed134	2025-06-09	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5	2025-06-01	Warnings	Exact identifier application applno (ANDA): 210137 application number: ANDA210137

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	c18f3207-92ad-4999-99c8-b51a1edcece3	8
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	c18f3207-92ad-4999-99c8-b51a1edcece3	8
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	c18f3207-92ad-4999-99c8-b51a1edcece3	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-0122-1	68210012201	100 TABLET in 1 BOTTLE (68210-0122-1)	100 tablet	2019-03-22	0000-00-00	No	No	Current
68210-0122-3	68210012203	1 BOTTLE in 1 CARTON (68210-0122-3) > 30 TABLET in 1 BOTTLE	1 bottle	2020-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valumeds FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg	Spirit Pharmaceuticals LLC	2024-12-13	HUMAN OTC DRUG LABEL	8