Fexofenadine

Product NDC: 73581-012
Requested package NDC: 73581-012-01
11-digit product format: 735810012
Labeler code: 73581
Product ID: 73581-012_579c7ff9-0c45-1d46-e063-6294a90aef34
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine
Dosage form: TABLET
Route: ORAL
Labeler: YYBA Corp
Application: ANDA219032
Marketing category: ANDA
Marketing start: 2026-07-27
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: 2027-12-31
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
A219032-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL			2025-02-28
A219032-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2025-02-28

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.

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	A219032-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2025-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219032-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2025-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219032-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2025-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219032-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2025-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219032-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2025-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219032-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2025-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219032-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2025-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219032-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2025-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219032-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2025-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219032-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2025-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219032-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2025-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219032-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2025-02-28	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219032-001	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2025-02-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219032-002	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2025-02-28	`a50c72e98297…`

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
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
579c7ff9-0c44-1d46-e063-6294a90aef34	Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine	FEXOFENADINE	YYBA Corp	579c7ff9-0c44-1d46-e063-6294a90aef34	2026-07-27	Warnings	Exact identifier application applno (ANDA): 219032 application number: ANDA219032 ndc (package): 73581-012-01 ndc (product): 73581-012 ndc11 (package): 73581001201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE
E6582LOH6V	FEXOFENADINE	83799-24-0	Fexofenadine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73581-012-01	73581001201	100 TABLET in 1 BOTTLE (73581-012-01)	100 tablet	2026-09-01	No	No	Current