Fexofenadine hydrochloride

Product NDC: 10202-229
11-digit product format: 102020229
Labeler code: 10202
Product ID: 10202-229_d5914c05-e8db-4c79-82d0-a279d1304118
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: 7-eleven
Application: ANDA202039
Marketing category: ANDA
Marketing start: 2015-01-15
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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2014-11-19
A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2014-11-19
A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2014-11-19

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 4 · 126 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	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`1e350fbaab3a…`

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
d5914c05-e8db-4c79-82d0-a279d1304118	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
10202-229-66	Fexofenadine hydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1		1
10202-229-66	Fexofenadine hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10202-229	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [7-ELEVEN]	1	Current NDC, Legacy NDC, 2 package rows	20190621_d5914c05-e8db-4c79-82d0-a279d1304118.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	5413d84e-f945-4920-8981-f62978f21d67	2026-08-06	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	683cb2ea-c913-48f4-8adc-2888da3b655e	2026-08-06	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Aurohealth LLC	eb8e67dc-e2df-4c35-bfd7-12af67e1354a	2026-08-06	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	7-eleven	d5914c05-e8db-4c79-82d0-a279d1304118	2019-06-20	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039 ndc (product): 10202-229

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	d5914c05-e8db-4c79-82d0-a279d1304118	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	d5914c05-e8db-4c79-82d0-a279d1304118	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	d5914c05-e8db-4c79-82d0-a279d1304118	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10202-229-66	10202022966	1 BLISTER PACK in 1 CARTON (10202-229-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2015-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine hydrochloride - 7-eleven \| Aurolife Pharma, LLC	7-eleven \| Aurolife Pharma, LLC	2019-06-20	Human OTC Drug Label	1