Fexofenadine hydrochloride

Product NDC: 68071-1896
Requested package NDC: 68071-1896-3
11-digit product format: 680711896
Labeler code: 68071
Product ID: 68071-1896_bbf66c17-1c0d-35a9-e053-2995a90a6783
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA202039
Marketing category: ANDA
Marketing start: 2015-01-15
Marketing end: 0000-00-00
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 180 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-1896	68071-1896-3	D	Discontinued by firm		2026-08-03

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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A202039-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2014-11-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202039-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2014-11-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202039-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2014-11-19	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 hydrochloride	FEXOFENADINE HYDROCHLORIDE	7-eleven	d5914c05-e8db-4c79-82d0-a279d1304118	2019-06-20	Warnings	Exact identifier application applno (ANDA): 202039 application number: ANDA202039

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1896-3	2024-07-16	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c
68071-1896-9	2024-07-16	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c
68071-1896-3	2023-01-30	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c
68071-1896-9	2023-01-30	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c
68071-1896-3	2021-02-22	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c
68071-1896-9	2021-02-22	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c
68071-1896-3	2021-01-29	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c
68071-1896-9	2021-01-29	C162847	48780-1	ba0f9c33-25d2-a910-e053-dadaa90a0b85	4bce3ec1-d120-62ba-e054-00144ff8d46c

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1896-3	68071189603	30 TABLET, FILM COATED in 1 BOTTLE (68071-1896-3)	2017-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexofenadine hydrochloride - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2021-02-22	HUMAN OTC DRUG LABEL	3