Fexofenadine hydrochloride

Product NDC: 68001-439
11-digit product format: 680010439
Labeler code: 68001
Product ID: 68001-439_bd31cd71-9281-7667-e053-2995a90a4ac0
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA076502
Marketing category: ANDA
Marketing start: 2020-06-19
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 60 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

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

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076502-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2006-04-11
A076502-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2006-04-11
A076502-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2006-04-11
A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-12
A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-12
A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-12
A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-12
A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-12
A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-12

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 10 · 369 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076502-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076502-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076502-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076502-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076502-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076502-001	AB	1	`8072bd15b7f6…`

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	60 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997420	Internal RxNorm lookup
997501	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
a86aebd0-937e-5d73-e053-2995a90a656a	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
68001-439-00	Fexofenadine hydrochloride	100 in 1 BOTTLE	TABLET	100		2
68001-439-00	Fexofenadine hydrochloride	1 in 1 CARTON	TABLET	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-439-00	EA - Each	68001-439	62c873d1-5a8e-4c1f-85bb-9bb11fcbabed	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-439	FEXOFENADINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	2	Current NDC, Legacy NDC, 2 package rows	20210317_a86aebd0-937e-5d73-e053-2995a90a656a.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	BluePoint Laboratories	a86aebd0-937e-5d73-e053-2995a90a656a	2026-07-13	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502 ndc (product): 68001-439
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	864e3052-5787-bf11-9d17-11274ca2304f	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	b0121213-eae1-8429-9986-3b3b26f35e47	2026-07-09	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Non-Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TARGET CORPORATION	3cf4b7fe-b1f7-b767-430a-655408f91753	2025-08-01	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	MAJOR PHARMACEUTICALS	0a6da401-a8a3-5d0b-f37e-c220838f7e49	2025-07-27	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	b961985e-0c18-b36f-d82e-32ff2d46fada	2025-07-18	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dollar General	1b2a14a1-a5cc-4f5e-8127-57e9d913f50a	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	KROGER COMPANY	7b146260-c925-3238-d092-24b7101ceb50	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	624b3a91-af4f-8848-6fc3-392e0df34cc8	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Health Corp.	204506d7-7688-fd7e-0aae-142b698848ef	2024-11-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	de438313-9790-b4ea-2d28-7a19836cf5e2	2023-04-21	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Rite Aid Corporation	af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce	2022-06-12	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Wal-Fex	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	95d420ea-6337-304f-54c3-0c75be1608e2	2022-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Family Dollar Stores, Inc.	f532e9d5-6457-8bef-e83e-16050f20b03c	2020-02-19	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Sam's West Inc.	1c1f43c4-7128-37c4-83fe-7eefac3fd477	2019-10-07	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway Inc	3c30a1dc-a13d-2522-d4d0-00c1e9dbab07	2017-12-11	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Consortium, LLC	d1d8d0ec-2bdd-fb07-a051-d6353e3c240c	2014-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Associate	8a1de8a1-808a-bc08-6c74-957d6f388eab	2014-01-22	Warnings	Exact identifier application applno (ANDA): 076502 application number: ANDA076502

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	a86aebd0-937e-5d73-e053-2995a90a656a	2
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	a86aebd0-937e-5d73-e053-2995a90a656a	2
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	a86aebd0-937e-5d73-e053-2995a90a656a	2
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	a86aebd0-937e-5d73-e053-2995a90a656a	2
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	a86aebd0-937e-5d73-e053-2995a90a656a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-439-00	68001043900	1 BOTTLE in 1 CARTON (68001-439-00) / 100 TABLET in 1 BOTTLE	1 bottle	2020-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine HCl Tablets USP	BluePoint Laboratories \| DR. REDDY'S LABORATORIES LIMITED \| Dr. Reddy's Laboratories Limited (FTO III)	2026-07-13	HUMAN OTC DRUG LABEL	3