FEXOFENADINE HYDROCHLORIDE

Product NDC: 68210-1220
Requested package NDC: 68210-1220-1
11-digit product format: 682101220
Labeler code: 68210
Product ID: 68210-1220_a0feb313-c93c-ba84-e053-2a95a90a9d1e
Type: HUMAN OTC DRUG
Nonproprietary name: FEXOFENADINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Spirit Pharmaceuticals LLC
Application: ANDA210137
Marketing category: ANDA
Marketing start: 2020-03-16
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 180 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	68210-1220	68210-1220-1	D	Discontinued by firm		2026-08-10

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 · 12 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…`

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

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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210137-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2018-08-13	`cb3db0bc1861…`

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-1220-1	68210122001	1 BLISTER PACK in 1 BLISTER PACK (68210-1220-1) > 4 TABLET in 1 BLISTER PACK	1 blister pack	2020-03-16	0000-00-00	No	No	Current