DESLORATADINE

Product NDC: 50090-4794
11-digit product format: 500904794
Labeler code: 50090
Product ID: 50090-4794_e682431d-3333-4fcb-8457-38b3e045b723
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DESLORATADINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078352
Marketing category: ANDA
Marketing start: 2013-02-25
Substance: DESLORATADINE
Active strength: 5 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	50090-4794	50090-4794-1	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4794-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4794-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4794-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4794-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4794-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4794-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4794-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4794-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4794-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4794-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4794-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4794-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4794-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4794-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4794-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4794-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4794-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4794-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4794-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078352-001	DESLORATADINE	DESLORATADINE	5MG	TABLET / ORAL	AB		2010-10-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078352-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078352-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-10-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078352-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078352-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078352-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078352-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078352-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078352-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078352-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078352-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078352-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078352-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078352-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078352-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078352-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078352-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078352-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078352-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078352-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078352-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078352-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078352-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078352-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078352-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078352-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078352-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078352-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078352-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078352-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078352-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078352-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078352-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078352-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078352-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078352-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078352-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078352-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078352-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078352-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078352-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078352-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078352-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: DESLORATADINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESLORATADINE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FVF865388R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349420	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
69b9635b-c790-4316-a790-67b0f5512b72	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
01632a31-f1c5-44ea-aa59-efded68c0797	Product name	1	20150716
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-4794-0	2023-02-07	These highlights do not include all the information needed to use DESLORATADINE TABLETS safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
50090-4794-1	2023-02-07	These highlights do not include all the information needed to use DESLORATADINE TABLETS safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
50090-4794-0	2023-01-30	These highlights do not include all the information needed to use DESLORATADINE TABLETS safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
50090-4794-1	2023-01-30	These highlights do not include all the information needed to use DESLORATADINE TABLETS safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4794-0	DESLORATADINE	90 in 1 BOTTLE	TABLET, FILM COATED	90		12
50090-4794-1	DESLORATADINE	30 in 1 BOTTLE	TABLET, FILM COATED	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4794-0	EA - Each	50090-4794	3c2a017e-c9fe-46d5-bcb1-58a9e57f3028	1	2025-08-11

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
DESLORATADINE	DESLORATADINE	Lupin Pharmaceuticals, Inc.	2a90b899-7746-43dc-ac8a-e754428eb30c	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078352 application number: ANDA078352
DESLORATADINE	DESLORATADINE	Bryant Ranch Prepack	f84c8de3-a7d3-4e8b-bfb6-04259e79450a	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078352 application number: ANDA078352
DESLORATADINE	DESLORATADINE	A-S Medication Solutions	a3b61ab9-ec20-4831-b69a-fcd913fce540	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078352 application number: ANDA078352
DESLORATADINE	DESLORATADINE	A-S Medication Solutions	69b9635b-c790-4316-a790-67b0f5512b72	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078352 application number: ANDA078352 ndc (product): 50090-4794

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FVF865388R	DESLORATADINE	100643-71-8	DESLORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349420	desloratadine 5 MG Oral Tablet	PSN	69b9635b-c790-4316-a790-67b0f5512b72	12
349420	desloratadine 5 MG Oral Tablet	SCD	69b9635b-c790-4316-a790-67b0f5512b72	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4794-0	50090479400	90 TABLET, FILM COATED in 1 BOTTLE (50090-4794-0)	2019-12-12	0000-00-00	No	No	Current
50090-4794-1	50090479401	30 TABLET, FILM COATED in 1 BOTTLE (50090-4794-1)	2019-12-12	0000-00-00	No	No	Current