Fexofenadine Hydrochloride

Product NDC: 45802-847
11-digit product format: 458020847
Labeler code: 45802
Product ID: 45802-847_e43b561e-d68a-47af-be93-d710f0f77505
Type: HUMAN OTC DRUG
Nonproprietary name: fexofenadine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA212971
Marketing category: ANDA
Marketing start: 2022-01-07
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212971-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL			2020-02-24
A212971-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2020-02-24

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212971-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2020-02-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212971-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2020-02-24	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
e43b561e-d68a-47af-be93-d710f0f77505	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
45802-847-78	Fexofenadine Hydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1		1
45802-847-78	Fexofenadine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-847-78	EA - Each	45802-847	b2089e13-e809-4a2f-ae96-a312487594b6	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-847	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]	1	Current NDC, Legacy NDC, 2 package rows	20220223_e43b561e-d68a-47af-be93-d710f0f77505.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Proficient Rx LP	4a9b4b7f-0441-44d3-86c7-2542ef4b119a	2022-12-01	Warnings	Exact identifier application applno (ANDA): 212971 application number: ANDA212971
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	e43b561e-d68a-47af-be93-d710f0f77505	2022-02-22	Warnings	Exact identifier application applno (ANDA): 212971 application number: ANDA212971 ndc (product): 45802-847
allergy relief	FEXOFENADINE HYDROCHLORIDE	Publix Super Markets Inc	76014f1e-fa48-4d64-9ce6-1eaebd0419fc	2022-01-21	Warnings	Exact identifier application applno (ANDA): 212971 application number: ANDA212971

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	4a9b4b7f-0441-44d3-86c7-2542ef4b119a	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	e43b561e-d68a-47af-be93-d710f0f77505	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	4a9b4b7f-0441-44d3-86c7-2542ef4b119a	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	e43b561e-d68a-47af-be93-d710f0f77505	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	4a9b4b7f-0441-44d3-86c7-2542ef4b119a	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	e43b561e-d68a-47af-be93-d710f0f77505	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-847-78	45802084778	1 BOTTLE in 1 CARTON (45802-847-78) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts	Bryant Ranch Prepack	2024-01-18	HUMAN OTC DRUG LABEL	102
Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts	Proficient Rx LP	2022-12-01	HUMAN OTC DRUG LABEL	1
Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts	Padagis Israel Pharmaceuticals Ltd	2022-02-22	HUMAN OTC DRUG LABEL	1