Application 210137

Type: ANDA
Sponsor: UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68210-0122	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Spirit Pharmaceuticals LL	ANDA	Current
68210-0122	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Spirit Pharmaceuticals LLC	ANDA	Current
68210-0122	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Spirit Pharmaceuticals LLC	ANDA	Current
68210-0122	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Spirit Pharmaceuticals LLC	ANDA	Current
68210-0122	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Spirit Pharmaceuticals LLC	ANDA	Current
68210-1220	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4148	FEXOFENADINE HCl	FEXOFENADINE HCl	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4148	FEXOFENADINE HCl	FEXOFENADINE HCl	Spirit Pharmaceuticals LLC	ANDA	Current
68210-4148	FEXOFENADINE HCl	FEXOFENADINE HCl	Spirit Pharmaceuticals LLC	ANDA	Current
72476-121	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES, LLC	ANDA	Current
72476-126	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES, LLC	ANDA	Current